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- 2025-12-23 21:07:24
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- US-expanded Cresemba faces reimb challenges in KOR
- by Son, Hyung-Min Dec 15, 2023 05:51am
- The antibiotic Cresemba has received expanded indications in the US to include pediatric patients. However, in Korea, the reimbursement for Cresemba is being delayed because of challenges in economic evaluations, limiting patient access to this medication. According to the industry on the 15th, the U.S. Food and Drug Administration (FDA) approved an expanded indication for Cresemba (isavuconazonium sulfate) for use in pediatric patients 1 to 17 years of age. Cresemba’s prescribed injection is indicated for 1 year and older, whereas the prescribed capsule is indicated for children 6 years of age and older (weight of 16kg or more). PfizerDue to the approval, Cresemba is now the only azole antifungal treatment approved by the FDA for use in pediatric patients with invasive aspergillosis and invasive mucormycotic. Cresemba is an antibiotic (antifungal agent) jointly developed by Switzerland's Basilea Pharmaceutica and Japan's Astellas Pharma. Pfizer holds the rights for commercial release in the European region and the distribution rights in Asia-Pacific regions, including Korea. Astellas has received approval for Cresemba in the US and Japan. The expanded indication approval for Cresemba was based on findings from the two Phase II clinical studies. The researchers assessed the safety and efficacy of Cresemba for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in 31 patients aged 1 to 17. The clinical result has shown that 54.8% of patients were able to achieve a successful response rate. In terms of safety, the most common adverse effects observed in Cresemba-treated pediatric patients were abdominal pain, rash, and injection site reaction. All-cause mortality rates through days 42 and 84 were 6.5% and 9.7%, respectively. There have been no reports of death related to the treatments. In addition, the FDA granted pediatric exclusivity for CRESEMBA, extending its period of market exclusivity in the US by an additional six months. Despite expanded use of Cresemba, the reimbursement of antifungal drugs is pending. While the indication for Cresemba is expanding overseas, its reimbursement is challenging in Korea. Cresemba has been approved in Korea in 2020 for the treatment of IA and IM in adults aged 18 and older. MSDYet, the discussion for reimbursement approval is still pending. Antibiotics include antibacterial drugs effective against bacteria, antifungal drugs effective against fungal infections, and antiviral drugs effective against viruses. Currently, antifungal and antiviral drugs are not included in the range of drugs exempted from the economic evaluation (cost-effectiveness assessment exemption). The government has granted cost-effectiveness assessment exemption to antibacterial products, but it views the inclusion of antifungal products as not aligning with the criteria of severity and urgency. However, there is an increasing demand for the inclusion of new antifungal drugs in reimbursement. This is in response to the escalating global prevalence of fungal infections. Despite this need, there have been no recent cases of new antifungal drugs being reimbursed. Since 2014, MSD's Zerbaxa (ceftolozane·tazobactam), Dong-A ST's Sivextro (tedizolid), Cresemba, and Pfizer's Zavicefta (ceftazidime·avibactam) have been approved in Korea. Among these, only Zerbaxa has been included in the reimbursement. Zavicefta, an antibacterial drug, is currently in pricing negotiations with the National Health Insurance Service. Sivextro, also an antibacterial drug, was withdrawn from the market in 2020, primarily due to challenges such as low pricing and the absence of insurance coverage.
- Company
- Domestic market withdrawal of Forxiga remains a mystery
- by Kim, Jin-Gu Dec 14, 2023 05:47am
- Pic of ForxigaAstraZeneca’s decision to withdraw its SGLT-2 inhibitor diabetes drug Forxiga (dapagliflozin) from the Korean market is being considered an unusual move by the industry. This is because the decision to pull out of the Korean market would essentially mean giving up KRW 50 billion in annual sales for AstraZeneca. While AstraZeneca's official position is that the decision is part of the company’s "portfolio overhaul," the mysteries surrounding the decision are not expected to be resolved anytime soon. Therefore, the industry's eyes are on AstraZeneca's next move, especially as it has been in stark contrast with MSD’s treatment of Januvia (sitagliptin). MSD Korea, which had faced a similar situation with Januvia, had sold its domestic sales rights for a large sum to a Korean company. #SB Company suddenly decides to withdraw ‘Forxiga,’ whose prescription sales exceed KRW 50 billion from the Korean market#EB According to industry sources on the 12th, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. The withdrawal is limited to the single-agent drug Forxiga. Its metformin combination Xigduo, sitagliptin combination Sidapvia, and saxagliptin combination Qtern will continue to be supplied through local pharmaceutical companies. Forxiga is an SGLT-2 inhibitor class diabetes drug. It was approved in Korea in 2013. Since then, it has rapidly increased its prescription sales. The annual prescription amount for the drug exceeded 30 billion won in 2019 and reached the 50 billion won mark last year. Yearly prescriptions of Forxiga (Unit: KRW 100 million, Data: UBIST). In Korea, it had dominated the SGLT-2 inhibitor market with Boehringer Ingelheim Korea’s 'Jardiance empagliflozin).’ Among single-agent drugs, prescriptions had been KRW 51 billion for Forxiga and KRW 48.3 billion for Jardiance last year. Sales of Astellas' Suglet (ipragliflozin) and MSD's Steglatro (ertugliflozin) accounted for less than KRW 5 billion during the same period. The joint sales agreement AstraZeneca had made with Daewoong Pharmaceutical is said to have contributed to the increase in prescription performance in Korea. Daewoong has been jointly selling Forxiga since 2018. The agreement between the two companies will end at the end of this year. Forxiga's rise to prominence hit a major inflection point earlier this year. Forxiga’s substance patent expired in April. More than 60 pharmaceutical companies launched generic versions of Forxiga upon patent expiry. This coincided with reimbursement for the use of SGLT-2 and DPP-4 inhibitor combinations, heralding a very fierce competition between the original and generic companies. AstraZeneca Korea deployed an aggressive defense strategy to maintain Forxiga’s position in the market. It filed an administrative appeal against the price reduction made upon entry of the generic version. At the same time, it applied for an injunction for the stay of execution of the government's price reduction. The court granted the request. As a result, the price of Forxiga is set to remain at the same level until February next year. AZ "Drug price reduction disposition unreasonable”…U-turns its stance after half a year The enforcement order was cited on June 1. However, just over 6 months later, AstraZeneca Korea decided to withdraw Forxiga from the Korean market. This is a 180-degree turnaround for the company, as this means the company decided to abandon Forxiga just half a year after it challenged the Ministry of Health and Welfare's decision to lower the drug's price with an administrative lawsuit. AstraZeneca's official position is that it is "discontinuing the domestic supply of Forxiga to realign the company's portfolio." On the surface, this seems to indicate that the company intends to reorganize its portfolio around anti-cancer drugs such as Tagrisso, Imfinzi, and Lynparza and focus on related businesses. In the industry, there are also assumptions that the market withdrawal decision was driven by the rush of generics that entered upon patent expiry and the pressure of excessive competition. Others argue that AstraZeneca Korea has exhausted resources and accumulated fatigue negotiating with the government to expand reimbursement for its Forxiga and other key products such as Tagrisso. However, those who believe otherwise point to how Forxiga's influence in the market remains strong even though more than 60 companies have launched generic versions of the drug. In fact, Forxiga's outpatient prescription performance has increased slightly YoY after the release of its generics. In Q2, Forxiga's prescriptions totaled to KRW 14.1 billion, up 15% YoY. In Q3, prescriptions increased 4% YoY to reach KRW 13.7 billion. While generic products generated KRW 3.9 billion in prescriptions in Q2 and KRW 6.8 billion in Q3, they did so by opening up new markets rather than by taking over Forxiga's share. Moreover, Forxiga’s indication was being expanded to not only diabetes but also heart failure and kidney disease. Forxiga has recently added a series of indications. They were for ▲ the treatment of heart failure with reduced ejection fraction (HFrEF), ▲ left ventricular ejection fraction/ heart failure with preserved ejection fraction (HFpEF)/heart failure with mildly reduced ejection fraction (HFmrEF), and ▲ chronic kidney disease (CKD). Of these, the company had applied for the drug’s reimbursement in HFrEF and CKD. The company was also reportedly conducting negotiations with the government for reimbursement extensions until recently. From AstraZeneca's point of view, extending Forxiga's reimbursement to heart failure could have further increased the prescription amount. In contrast with MSD's sale of Januvia rights … Competition will intensify to close the KRW 50 billion void The pharma industry focused on how MSD decided to sell Januvia’s domestic sales rights before patent expiry. Pic of JanuviaJanuvia is a DPP-4 inhibitor class diabetes drug. Januvia has various similarities to Forxiga, such as the fact that it is a flagship item with a prescription value of KRW 42.6 billion last year and a large number of generics were launched after its patent expiry in July this year. In May, Chong Kun Dang signed a licensing agreement with MSD to acquire domestic rights for 3 products - Januvia, Janumet, and Janumet XR. Chong Kun Dang will acquire all domestic sales, distribution, licensing, trademark, and manufacturing rights for the 3 Januvia series drugs. The contract amount was 45.5 billion won. Chong Kun Dang paid MSD an upfront payment of KRW 23 billion and additional milestone payments of KRW 22.5 billion based on sales performance. MSD made a considerable profit by handing over all domestic rights for the antidiabetic drugs to Chong Kun Dang ahead of Januvia's patent expiration, at a time when generics were expected to be launched. The deal was seen as a win-win, as MSD could focus on sales and marketing of its other products instead of competing with domestic drugmakers, and Chong Kun Dang could secure a stable cash cow that brings in over KRW 100 billion a year. On the other hand, AstraZeneca made a contrasting move, deciding to withdraw from the Korean market instead of selling the rights for Forxiga to a Korean company. The company had made no moves to sell Forxiga's domestic rights to any company. AstraZeneca also drew the line regarding its plans to resupply Forxiga in Korea. An AstraZeneca Korea official said, "We have secured enough domestic supply to last until the first half of next year. We are discussing patient protection measures with the Ministry of Food and Drug Safety. However, at this time, we are not considering resupplying the drug after the first half of next year."
- Company
- Rinvoq is granted reimb for ankylosing spondylitis
- by Son, Hyung-Min Dec 14, 2023 05:47am
- AbbVie Korea holds press conference in celebration of Rinvoq’s reimbursement approval in ankylosing spondylitis on the 13th The use of JAK inhibitors, which had been used for rheumatoid arthritis and atopic dermatitis, has been expanded to ankylosing spondylitis. On the 13th, AbbVie Korea held a press conference at Andaz Seoul Gangnam in Gangnam-gu, Seoul to celebrate the reimbursement of its Janus kinase (JAK) inhibitor, Rinvoq (upadacitinib) for severe active ankylosing spondylitis. Rinvoq was granted reimbursement for the treatment of adults with severe active ankylosing spondylitis on the 1st. Rinvoq is reimbursed for use in patients with severe active ankylosing spondylitis who have had an inadequate response to or had to discontinue treatment with tumor necrosis factor-alpha (TNF-α) blockers or interleukin (IL)-17 inhibitors. With the reimbursement extension, Rinvoq can now be used to treat patients with ankylosing spondylitis in addition to other inflammatory diseases such as atopic dermatitis, rheumatoid arthritis, and ulcerative colitis. Its efficacy and safety were confirmed in adult patients with active ankylosing spondylitis through the SELECT-AXIS 1 Phase II/III study and the SELECT-AXIS 2 Phase III study. In the SELECT-AXIS 1 study, which included patients naïve to biologic disease-modifying drugs, the Rinvoq arm achieved a 52% response rate at Week 14 in terms of ASAS40 (defined as a ≥40% improvement in response per Assessment of SpondyloArthritis International Society standards), which was higher than the placebo arm. In the SELECT-AXIS2 study, which observed patients who had failed biologic therapy, the ASAS40 response in the Rinvoq arm was 45% at week 14, demonstrating an efficacy compared to the 18% in the placebo arm. The mean reduction in pain was -3.00 in the Rinvoq arm and -1.47 in the placebo arm. Unmet needs remain in ankylosing spondylitis…Rinvoq and other JAK inhibitors emerge as alternatives #I2Ankylosing spondylitis is an autoimmune disease in which the spine joint becomes inflamed and gradually stiffens. Inflammation of the spinal joints causes pain, stiffness, and other symptoms. If left untreated, the joints can become stiff and become immobile. The number of affected patients has been increasing steadily every year. According to the Health Insurance Review and Assessment Service’s Healthcare Big Data, the number of patients with ankylosing spondylitis in Korea was 52,616 in 2022, showing a steady increase over the past 5 years. Results of a treatment satisfaction survey conducted on patients with ankylosing spondylitis showed that about half of patients are dissatisfied with their current treatment. Despite significant improvements in clinical outcomes, unmet needs remain in achieving remission, pain control, fatigue, and psychological issues (anxiety, depression). Therefore, it is analyzed that the reimbursement of JAK inhibitors, such as Xeljanz (tofacitinib) and Rinvoq, will be able to improve patient outcomes. Seung-Jae Hong, Professor of Rheumatology at Kyung Hee University Hospital, said, "I believe that the introduction of oral agents such as Rinvoq for the treatment of ankylosing spondylitis will greatly benefit patients. As Xeljanz is considered to be associated with a high risk of cardiovascular disease (CVD) based on the clinical results, we believe Rinvoq would become a more popular reimbursed choice in the field."
- Company
- Reimb of latecomer leukemia drug Bosulif imminent
- by Eo, Yun-Ho Dec 14, 2023 05:47am
- Bosulif, a new leukemia treatment, is expected to receive reimbursement next year. According to the pharmaceutical industry, Pfizer Korea successfully completed drug pricing negotiations with the National Health Insurance Service for Bosulif (bosutinib), a Chronic Myelogenous Leukemia (CML) treatment. Bosulif will be presented to the Health Insurance Policy Review Committee of the Ministry of Health and Welfare, and if approved, it will be reimbursed starting in January 2024. Following its FDA approval in 2012, Bosulif was authorized for use much later in Korea, in last January. Bosulif is a second-generation targeted therapy similar to Novartis Korea’s Tasigna (Nilotinib), BMS Korea’s Sprycel (Dasatinib), and Il-Yang Pharmaceutical’s Supect (Radotinib). Given that there are already established drugs in the same category, no difficulties are expected in the course of its reimbursement approval. The efficacy and safety of Bosulif has been confirmed in Phase 3 NCT02130557 study, which enrolled newly-diagnosed CML patients. The primary endpoint of Bosulif was major molecular response (MMR) by 12 months. Bosulif-treated patients had MMR of 47%. Patients treated with the comparator drug, first generation drug Gleevec (imatinib), had MMR of 36%. MMR by Month 60 was 74% for Bosulif versus 66% for Gleevec. After 60 months of follow-up, the median time to MMR in responders was 9.0 months for bosutinib and 11.9 months for Gleevec. Many next-generation targeted therapies are already available in the field. These include the third-generation Korea Otsuka Pharmaceutical's Iclusig (Ponatinib), and a fourth-generation Norvatis’ Scemblix (Asciminib).
- Company
- Daewoong attempts at first Lupron Depot generic in the US
- by Chon, Seung-Hyun Dec 13, 2023 05:38am
- Daewoong Pharmaceutical is seeking to enter the U.S. anticancer market with the global pharmaceutical company, Zydus Worldwide DMCC. Daewoong Pharmaceutical announced on the 11th that it had signed a licensing agreement with Zydus Worldwide DMCC. to co-develop and commercialize the anticancer drug DWJ108U Depot suspension injection. The value of the agreement is estimated to be near KRW 12.22 billion at most. This includes an upfront payment of $9.24 million (KRW 12.2 billion), development and commercialization milestones of $2.55 million (KRW 3.4 billion), and an additional supply agreement worth $66.89 million (KRW 88.5 billion). Under the agreement, Zydus will be assuming full responsibility for the joint clinical development and commercialization of Daewoong’s Depo injection product in the US market. The contract term is seven years after launch in the US and may be subject to change depending on the drug’s release date in the US. DWJ108U, which is being jointly developed by Daewoong Pharmaceutical and Zydus, is the first generic of ‘Lupron Depot’ to be introduced to the US. Lupron Depot was released in the US in 1898, but due to the difficulty of developing a generic version of the drug, no generic product has ever passed the Abbreviated New Drug Application (ANDA) process in the U.S. market. The US leuprolide acetate market is valued at approximately $1.6 trillion, with Lupron Depot holding a dominant position in the market. Daewoong Pharmaceutical's DWJ108U utilizes the emulsion principle to encapsulate the drug in microscopic polymer particles, which is the same manufacturing method as the original Lupron Depot. If DWJ108U is approved as a generic for Lupron Depot in the United States, it will be approved for 4 indications at once - prostate cancer, premenopausal breast cancer, endometriosis, and uterine fibroids. Daewoong Pharmaceutical will be responsible for the pre-clinical studies, production, and supply of the product, with Zydus pursuing its clinical development and commercialization in the US market. Seng-Ho Jeon, CEO of Daewoong Pharmaceutical, said, “Although Lupron Depot has been in the US market for 35 years, no single generic product to date has been introduced to date due to difficulties in its development. With Zydus, who owns a strong presence in the US market, we plan to complete the clinical trials of DWJ108U, the first generic version of Lupron Depo, and successfully introduce it to the US anticancer drug market." Sharvil Patel, Managing Director of Zydus Lifesciences, said, "The agreement is another step towards strengthening our injectable portfolio, and is an important step towards enabling access to affordable generic versions for patients in the US. This is an important milestone and we are happy to work with Daewoong for a generic version of Lupron Depot, and wish for its successful launch in the US.” Zydus Worldwide DMC is a wholly-owned subsidiary of Zydus Lifesciences, a global pharmaceutical group headquartered in Ahmedabad, India. The company owns 36 manufacturing sites worldwide. Fourteen of these facilities are US cGMP certified. The company is an expert in regulatory approvals, with more than 350 ANDAs approved in the U.S. alone. Last year, Zydus sales in the US market were approximately $1.2 trillion and total global sales were approximately $2.7 trillion.
- Company
- Jeil will exclusively supply Norvatis’ 9 ophthalmic drugs
- by Nho, Byung Chul Dec 12, 2023 10:33pm
- Jeil is venturing into the field of ophthalmic diseases for the first time. Jeil Pharmaceutical (CEO Sung Suk-Je) announced on the 11th that it has signed an exclusive distribution agreement with Novartis Korea (CEO Yoo Byung-Jae) for the sale and supply of nine drugs in ophthalmic diseases including glaucoma and conjunctivitis. to target the ophthalmic disease market. With this partnership, Jeil will be venturing into the field of ophthalmic diseases for the first time. Jeil plans to enter the market in Jan 2024 and establish its position in the field of ophthalmic diseases, including in glaucoma and conjunctivitis. Under the agreement, Jeil will receive exclusive sales and distribution rights in Korea for six glaucoma treatments and three conjunctivitis treatments from Novartis Korea. The nine drugs will include Elazop, Simbrinza, Azopt, Travatan, Izba, and Duotrav for ocular hypertension and open-angle glaucoma, zs well as Pazeo, Pataday, and Patanol for allergic conjunctivitis. These nine drugs recorded sales of 25 billion won in Korea last year, according to IQVIA. In particular, Elazop holds a 14% market share in the glaucoma eye drop combination market in Korea, rendering annual sales of over 11 billion won, and is also consistently prescribed in the global market. “We are pleased to be partnering with Novartis, a global healthcare company,” said Sung Suk-Je, CEO of Jeil Pharmaceutical. Sung added, “We will concentrate our efforts on broadly supplying these globally recognized, excellent ophthalmic disease treatments to improve the quality of life for patients in Korea.” “Novartis will focus on the sales of retinal disease treatments Beovu and Lucentis," said Yoo Byung-Jae, CEO of Novartis Korea. "Through our partnership with Jeil, which has strong competitiveness in terms of sales power at hospitals and clinics, we will make our best efforts to stably supply ophthalmic treatments, particularly glaucoma and allergy treatments, to patients and medical professionals in Korea.”
- Company
- Evenity and Prolia sales surge...combined sales rise 47%
- by Kim, Jin-Gu Dec 12, 2023 05:38am
- Amgen’s two osteoporosis treatments, Prolia (denosumab) and Evenity (romosozumab) are repeatedly posting high growth in sales. Together, these two treatments generated over 130 billion won in Q3 sales, dominating the osteoporosis treatment market in Korea. In the first-line, osteoporosis treatment is trending towards sequential Evenity followed by Prolia for high-risk fracture osteoporosis patients. With this approach increasingly becoming the norm, the analysis is that these two treatments are deemed to be making a synergistic effect, leading to improved outcomes. Prolia's Q3 cumulative sales up 33% YoY…over 150 bil won expected by the end of the year According to the market research institution IQVIA, Prolia’s cumulative sales in Q3 were 111.5 billion won, representing an increase of 33% year-over-year (YoY) from the 83.8 billion won last year. Prolia was approved in September 2014 in Korea. It is a biologic for osteoporosis that targets RANKL, an essential protein for the formation, function, and survival of osteoclasts that destroys the bone. Prolia began seeing an upward sales trend after its reimbursement as a second-line treatment in 2017. The sales growth became steeper after Prolia received expanded reimbursement as a first-line treatment in April 2019. Quarterly sales of Prolia In 2019, Prolia's sales were 47.3 billion won, and this nearly doubled to 92.1 billion won in 2021 over two years. Last year, its annual sales expanded to exceed 100 billion won. If the current sales growth continues, its annual sales are projected to reach close to 150 billion won by the end of the year. The analysis is that both the expansion of reimbursement and enhanced sales efforts contributed to Prolia's growth. Amgen has been co-marketing Prolia with Chong Kun Dang since September 2017. This method of collaboration involves Amgen focusing on general hospitals, while Chong Kun Dang handles the drug's sales and marketing in secondary hospitals and clinics. Evenity's salses rise 61% YoY… accelerated by Prolia’s sales growth Evenity, which was released following Prolia, is showing an even steeper growth. This year, its cumulative sales for Q3 reached 19.7 billion won, an increase of 61% YoY. Evenity is an osteogenic agent with a dual effect of promoting bone formation and inhibiting bone resorption. Amgen's strategy for marketing for Evenity is 'sequential Evenity followed by Prolia' regimen. Evenity is administered monthly for one year for patients with osteoporosis at high risk of fracture to rapidly increase bone density and reduce fracture risk. The patients are then administered Prolia, once every six months, to continue treatment over a longer period. The pharmaceutical industry’s analysis is that this treatment approach is increasingly becoming common in clinical prescription settings. Also, the analysis is that this sequential administration of Evenity followed by Prolia is contributing to the sales growth. Evenity was approved in Korea in June 2019. It was listed for reimbursement in Dec. 2020, which led to significant sales starting the following year. The sales from Evenity increased by 42%, from 12.3 billion won in 2021 to 17.4 billion won last year. It is forecasted that the sales will exceed 25 billion won by the end of this year. In fact, two treatments from Amgen have effectively dominated the osteoporosis treatment market in Korea. Combined, these two products recorded sales of 131.2 billion won up to Q3, representing a YoY increase of 37% from the 96 billion won recorded in the last year. Quarterly sales of major OP treatments With the rapid rise in sales of Amgen's two treatments, the existing bisphosphonate class of osteoporosis treatments generally showed poor performance. Hanmi Pharmaceutical's RaboneD Cap. recorded a 9% decrease in sales, down from 7.3 billion won in Q3 last year to 6.7 billion won in Q3 this year. Meanwhile, sales of Daewoong Pharmaceutical's Daewoong Zoledronic Acid Inj. also fell 20%, from 5.2 billion won to 4.1 billion won. During the same period, Jeil Pharmaceutical's Bonviva and Bonviva Plus recorded a 26% decrease in sales, dropping from 6.4 billion won to 4.7 billion won. Jeil Pharmaceutical has been in charge of the domestic sales of Bonviva and Bonviva Plus since October last year, taking over the rights from Handok. Bonviva Plus is Vitamin D reinforced version of Bonviva. Among the major bisphosphonate class treatments, Eli Lilly's Forsteo Inj. showed an increase in sales. Forsteo Inj.'s cumulative sales in Q3 amounted to 11.6 billion won, showing a growth of 19% YoY.
- Company
- AZ will withdraw its KRW 50 bil Forxiga from KOR mkt
- by Kim, Jin-Gu Dec 12, 2023 05:38am
- Forxiga (dapagliflozin), an SGLT-2 inhibitor class diabetes drug worth KRW 50 billion a year, will withdraw from the domestic market. According to industry sources on the 11th, AstraZeneca Korea recently made the decision to discontinue supply of Forxiga in Korea. However, the company will continue to supply its dapagliflozin and metformin combination drug Xigduo in Korea. An official from AstraZeneca told Dailypharm, "We have decided to discontinue the domestic supply of Forxiga in Korea to reorganize our portfolio. We have started discussions with the Ministry of Food and Drug Safety regarding withdrawing our marketing authorization. We will do our best to ensure that there is no interruption in domestic supply before withdrawing the drug in the first half of next year." The decision to discontinue the supply is deemed to have been made upon the expiration of Forxiga’s patent. Forxiga’s substance patent expired in April. Since then, a total of 60 companies have launched generic versions of Forxiga simultaneously, heralding fierce competition. Forxiga’s prescription performance has been declining ever since the launch of its generics. According to market research institution UBIST, Forxiga’s outpatient prescriptions in Q3 totaled at KRW 13.7 billion, up 4% YoY. However, this is the second consecutive quarter the drug saw a decline in sales from the KRW 14.5 billion it had posted in Q1 this year, just before its patent expiry. This is likely due to the increased competition following the release of the large number of generics. In fact, Forxiga’s generics generated prescription sales of KRW 5.9 billion in Q2 and KRW 10.6 billion in Q3. The generic's share of the dapagliflozin diabetes drug market has increased to 30% within 6 months of its launch. Quarterly prescriptions of Forxiga andn Xigduo Forxiga’s full withdrawal is expected to create a void worth KRW 50 billion in the diabetes treatment market. And this void is expected to be filled by Forxiga genetics and generics of another SGLT-2 inhibitor, Jardiance (empagliflozin). Also, generic competition is expected to intensify in the process. Forxiga was previously copromoted in Korea by Daewoong Pharmaceutical. Daewoong plans to fill the Forxiga gap with based on its SGLT-2 inhibitor diabetes drug, Envlo (enavogliflozin).
- Company
- Reimb at a halt for one-shot IRD drug Luxturna
- by Eo, Yun-Ho Dec 12, 2023 05:38am
- Reimbursement discussions for the one-shot retinal disease treatment Luxturna is being delayed in Korea. According to Dailypharm coverage, Novartis Korea failed to reach an agreement with the National Health Insurance Service on the drug price of uxturna (voretigene neparvovec) for inherited retinal dystrophy (IRD) within the 60-day deadline and will enter into extended negotiations. This suggests that the two parties involved (government-pharmaceutical company) were unable to reach an opinion regarding finances for the drug. Although the company had applied for reimbursement of the drug in September 2021, no progress had been made on its listing for a while and was finally presented as an agenda for deliberation by HIRA’s Drug Reimbursement Evaluation Committee in March this year. However, the drug failed to pass DREC review and receive reimbursement standards at the time. The company supplemented and reapplied for the drug’s reimbursement thereafter, thanks to which the company was able to start reimbursement negotiations. As disagreements over the terms of the risk-sharing agreement (RSA), including the refund rate, had previously stalled DREC deliberations, this may have played a role in stalling the pricing negotiations between NHIS and Novartis Korea as well. An official from Novartis said, “Luxturna is the only treatment option available for patients with IRD. As both the company and the government are well aware of this, we will do our best to overcome our differences within the extended negotiation period." Meanwhile, the efficacy of Luxturna was demonstrated through a Phase III trial that was conducted on IRD patients with confirmed biallelic RPE65 mutations. Study results showed that the group of patients that received Luxturna demonstrated statistically significant improvements in their functional vision compared to the control group at one year of treatment. Using the mean score of the multi-luminance mobility test (MLMT), which evaluates the ability to complete the obstacle course at low light levels by recreating the daily walking environment, as the primary endpoint at one year of treatment, the MLMT score change in the Luxturna treatment group was 1.8 points, 1.6 points higher than the 0.2 points in the control group.
- Company
- Taked’a new CMV drug Livtencity passes DREC review in 1 yr
- by Eo, Yun-Ho Dec 11, 2023 05:02am
- The reimbursement adequacy evaluation for the cytomegalovirus (CMV) treatment ‘Livtencity’ has been completed in 1 year since the drug received approval in Korea. According to industry sources, Takeda Pharmaceuticals Korea submitted its reimbursement application for Liventity (maribavir) in Q3, and the agenda has passed the review of the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee on the 7th of this month. Therefore, the company will now proceed to drug pricing negotiations with the NHIS if the Ministry of Health and Welfare gives the negotiation order. Whether negotiations will be successful, and a new treatment option will be introduced and rise as an alternative for patients who are resistant to existing drugs, remains to be seen. CMV is a type of herpes virus that's extremely common worldwide. Over 60% of all adults are infected with CMV within their lifetime and typically develops in patients who use immunosuppressants after hematopoietic stem cell transplantation (HSCT). Around 30-70% of HSCT patients experience CMV viremia. In HSCT patients, CMV causes multisystemic diseases such as pneumonia, hepatitis, gastroenteritis, retinitis, and encephalitis. Among these, pneumonia’s mortality rate is near 60%. Because CMV in immunocompromised patients is fatal, patients had generally received preemptive treatment mainly with ganciclovir, valganciclovir, foscarnet, and cidofovir, and hospitalization had been essential. Additionally, because these drugs have similar mechanisms of action, if resistance to one drug develops, likely, that the patient will not respond to other treatments as well. However, the introduction of Livtencity brings hope to these patients for secondary treatment. Livtencity has almost no side effects compared to existing drugs and offers an alternative if resistance to the existing treatments develops. Livtencity’s antiviral activity inhibits CMV multiplication and migration through a differentiated multi-modal mechanism of action that inhibits the protein kinase of the HCMV enzyme UL97. It not only inhibits DNA from coming out of cells, but also interferes with viral DNA replication, encapsidation, and nuclear egress. Meanwhile, Livtencity was first approved in November 2021 by the US FDA as the first treatment for patients with post-transplant CMV infection/disease and was approved in Korea in December last year. Also, Livtencity has passed the Drug Committees (DCs) of tertiary hospitals in Korea including Samsung Medical Center, Saint Mary's Hospital, Asan Medical Center, and Sinchon Severance Hospital, as well as other medical institutions such as the Kyungpook National University Hospital, Jeonbuk National University Hospital, and Chonnam National University Hwasun Hospital.
