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- 2026-05-14 05:31:36
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- Competition for chronic kidney disease following SGLT-2 I
- by Eo, Yun-Ho Dec 02, 2022 06:07am
- Competition for SGLT-2 inhibitors is expected to expand to the area of chronic kidney disease following heart failure. According to related industries, following AstraZeneca's Forxiga, Lilly and Beringer Ingelheim's Jardiance also succeeded in proving their effectiveness to secure chronic kidney disease indications. Forxiga is ahead in speed. After approval by the U.S. FDA in April, Forxiga immediately began the licensing process in major countries such as Korea and added chronic new disease indications in Korea and Europe in August. However, insurance benefits have not been applied so far. Forxiga's approval of chronic renal disease indication was based on phase 3 clinical DAPA-CKD study. Earlier this year, Forxiga was designated as a subject of the FDA-assigned Priority Review. According to the DAPA-CKD study, Forxiga reduced the relative risk of kidney failure compared to placebo, terminal kidney disease (ESKD), and death from cardiovascular or kidney by 39% in patients with stage 2-4 chronic kidney disease with increased UAE levels. ARR was 5.3% for 2.4 years, the median value of the study period. Jardiance recently announced the results of the EMPA-KIDNEY phase 3 at ASN's Kidney Week 2022. EMPA-KIDNEY was a study exclusively for a wide range of, large-scale SGLT-2 inhibitors, involving 6609 patients with various causes. Among them, many patients had cardiovascular, kidney, or metabolic-related comorbidities, and all kidney and cardiovascular results were evaluated according to the severity of various chronic kidney diseases. The previous SGLT-2 inhibitor study included the widest range of patients ever compared to a specific group with diabetes or high proteinuria among patients with chronic kidney disease. Looking at the study, Jardiance significantly reduced the risk of kidney disease progression or cardiovascular death by 28% compared to placebo. In addition, hospitalization due to all causes, one of the major complex secondary evaluation variables defined in advance, was significantly reduced by 14% compared to placebo. It was found that the results of hospitalization or cardiovascular death due to heart failure, a major secondary evaluation variable, or death reduction due to all causes were not statistically significant. Chronic kidney disease is a progressive disease, and it is investigated that up to 700 million patients around the world are distributed. Treatments that can be used in the patient group are limited, but it is necessary to enter new treatment options in that chronic kidney disease increases the incidence of cardiovascular events such as heart failure and affects early death.
- Company
- Balversa, the first targeted anticancer drug for bladder can
- by Dec 02, 2022 06:07am
- BalversaTargeted options targeting specific genetic mutations in bladder cancer have emerged for the first time. The Ministry of Food and Drug Safety announced on the 24th that it had approved Janssen's Balversa. It is an indication of metastatic urinary epithelial cancer (cystic cancer) with at least one type of chemotherapy treatment, or FGFR2 or 3 mutations within 12 months of adjuvant treatment before and after surgery, including platinum-based chemotherapy. Bladder cancer is representative cancer that had no targeted anticancer drugs. Balversa has become the first targeted anticancer drug for bladder cancer with a new mechanism called FGFR inhibition. FGFR is one of the bio-signals involved in cancer cell growth and is associated with several carcinomas. In particular, FGFR mutations are commonly observed in bladder cancer, and about 20 to 30% of patients are known to have mutations. The phase 2 BLC2001 study, which served as the basis for Balversa approval, targeted 99 patients with local progressive and metastatic urinary tract epithelial cancer with FGFR mutations. The ORR of 87 people who can be evaluated was 32.2% based on the IRRC evaluation. The disease control rate was 78% and the median response duration was 5.4 months. The progression-free survival (PFS) median and OS median were 5.5 months and 13.8 months, respectively. The most commonly reported adverse reactions of Grade 3 or higher include canker soreness, hand toenail dystrophy, hand toenail disorder, corneal inflammation, and hyperphosphatemia. Significant adverse reactions occurred in 41% of patients, of which eye disorders were reported by 10%. The adverse reactions that resulted in fatal results occurred in 1% of patients due to acute myocardial infarction. Based on the second phase, the Balversa permit was approved in April 2019, three years earlier than Korea in the U.S. To diagnose FGFR3 mutations, QuantiFERON's Therascreen FGFR Kit was also approved as a companion diagnostic device. ◆ A treatment for bladder cancer that has not existed for decades Bladder cancer is cancer that has been stagnant for decades. Unlike other cancers where several targeted anticancer drugs appeared, bladder cancer has been the main treatment until recently. The development of new drugs was not easy because of the high effectiveness of early chemotherapy. However, in metastatic bladder cancer, chemotherapy reacts in the early stages, and most of them die within two years due to resistance. The birth of the first targeted anticancer drug for bladder cancer Recently, immuno-cancer drugs have emerged, causing changes in the treatment of bladder cancer. There are four immuno-cancer drugs, including Keytruda, Opdivo, Tecentriq, and Bavencio, and there is a slight difference in specific indications. Keytruda and Tecentriq can be used as primary treatments. However, it can be used only when PD-L1 expression is positive and Cisplatin-based chemotherapy is impossible. Bavencio can be used as a maintenance therapy without the disease progressing after using chemotherapy in the first round. Opdivo is used as a secondary treatment when the disease progresses after chemotherapy. Keytruda and Tecentriq can also be used in the second round. Immuno-cancer drugs have a high response rate of around 20%, but they have fewer side effects than chemotherapy and have the advantage of maintaining treatment responses for a long time. With Balversa's permission, patients with FGFR mutations can consider targeted anticancer drugs in secondary or higher treatment, which is expected to help improve their prognosis.
- Company
- Ajovy will it be possible to register this year?
- by Eo, Yun-Ho Dec 01, 2022 05:46am
- Attention is focusing on whether the second CGRP target migraine drug Ajovy will be able to apply for insurance benefits within this year. According to related industries, Teva Handok is conducting last-minute coordination in drug price negotiations between the NHIS and the Calcitonin gene-related peptide (CGRP) target migraine treatment Ajovy. Considering that the benefit of Emgality in September, a competitive drug and the first entry item, has been applied, the negotiations have been delayed more than expected. Currently, there is no big disagreement with the calculation of drug prices itself, but factors such as the expected amount of claims are known to be an obstacle. Considering the negotiation date, if it goes according to the procedure, it is possible to register within this year, so we have to watch Ajovy's progress. If Ajovy succeeds in registering, competition between the two drugs is expected to begin in earnest. Emgality and Ajovy are the same drugs, and they are selected according to the characteristics of severe migraine patients. Emgality is a method of administering 240 mg (two consecutive subcutaneous injections each of 120 mg) once at a loading dose, and then subcutaneous injections of 120 mg once a month. Ajovy is used by subcutaneous injection of 225 mg once a month or 675 mg (three consecutive times of 225 mg) once every three months. Ajovy proved its effectiveness through a 12-week HALO EM/CM clinical trial in 2,000 patients with EM and CM. In a HALOEM study conducted to verify the efficacy and safety of Ajovy compared to the placebo group, Ajovy was evaluated to meet the primary evaluation variable by significantly reducing the number of monthly migraine occurrences in both monthly and quarterly administration groups. The proportion of patients whose average monthly migraine days decreased by more than 50% was also higher at 47.7% in the Ajovy monthly administration group and 44.4% in the quarterly administration group compared to 27.9% in the placebo group. In the HALOCM study, the average number of monthly headache reduction days in the Ajovy administration group was 4.6±0.3 days, and the quarterly administration group was 4.3±03 days, showing a significant decrease compared to 2.5±0.3 days in the placebo group.
- Company
- Expansion of Roche Polivy's indication of primary therapy
- by Eo, Yun-Ho Dec 01, 2022 05:46am
- From the Ministry of Food and Drug Safety, Roche Korea announced on the 28th that Polivy and Rituximab+Cyclophosphamide, Doxorubicin, and Prednisone combination therapy has been approved to expand the indication as the primary treatment for adult patients with diffuse large B-Cell Lymphoma whose have no previous treatment experience. Diffuse large B-Cell Lymphoma is a blood cancer with aggressive tendencies and is the most common form of non-Hodgkin lymphoma. In Korea, it is estimated that the number of new patients diagnosed with diffuse giant B cell lymphoma reaches 5,000 every year. Although the majority of patients responded to initial treatment, 4 out of 10 patients were not treated with the current standard treatment, and there was a demand for more effective primary treatments due to poor prognosis when the number of treatments increased. The permission to expand the indication was based on the results of the POLARIX study in phase 3 clinical trials. The study was followed for more than 24 months for all patients, and in the first-line treatment of diffuse giant B cell lymphoma during a 28.2 month follow-up period, Polivy, and R-CHHP combination therapy reduced the likelihood of disease exacerbation or death by 27% compared to R-CHOP. The most frequently reported adverse reactions during Polivy treatment (30% or more) were peripheral neuropathy (52.9%), nausea (41.6%), neutrophil reduction (38.4%), and diarrhea (30.8%). Nic Horridge, CEO of Roche Korea, said, "We have continued to innovate to meet the unmet demand of patients, and finally we can provide improved treatments to Korean patients. Through Polivy, the expansion of this indication can provide better results for more patients with diffuse giant B-cell lymphoma."
- Policy
- Roche’s Lunsumio receives 1st GIFT designation in Korea
- by Lee, Hye-Kyung Dec 01, 2022 05:46am
- The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) announced that it had designated Roche Korea’s ‘Lunsumio Inj (mosunetuzumab)’ as the first product subject to the Global Innovative product on Fast Track (GIFT) program it has been operating since September to support the development of innovative medical products in Korea. Lunsumio is used to treat adults with refractory or relapsed follicular lymphoma. With no other existing treatment options available for the disease, its urgent need for introduction had been recognized and designated as an item subject to the GIFT program. Drugs subject to GIFT receive various support for the rapid commercialization of its product including support for preparing approval data, rolling review support, and provided opportunities for close communication between the reviewer and developer, expert consulting on regulatory affairs, etc. The MFDS also newly established a page for GIFT on its webpage to ensure transparency in GIFT designations and allow easy access to related information in one place. The page provides information on GIFT and its main areas of support, eligibility for GIFT, the application process, submitted data, and the fast-track designation status of drugs, etc. As a result, information on Roche Korea’s Lunsumio Inj which received the first GIFT designation has also been disclosed on the GIFT information webpage. The information page can be accessed through www.mfds.go.kr → Public communication → active administration → GIFT The MFDS said, “We will continue to actively support the research and development of innovative new drugs and their rapid commercialization through the effective operation of the GIFT program.
- Policy
- The price of Donepezil 5mg fell below 500 won
- by Lee, Tak-Sun Dec 01, 2022 05:46am
- Dementia tx original AriceptDonepezil, which is most commonly used to treat dementia, fell to less than 500 won for 5mg due to the step-type drug price implemented in July 2020. The drug prices refer to 85% of the lowest price of the upper limit of the same product registered if more than 20 products are registered. According to industries on the 29th, Donepezil HCl applied by C.L.Pharm will be listed on the 1st of next month at 85% of the lowest price with step-type drug prices. Accordingly, C.L.Pharm's Bielpezil 5mg will be listed for 425 won and Bielpezil 10mg for 544 won. It has fallen to 85% from the previous lowest price product. In the case of 5mg of Donepezil HCl hydrate, 122 pharmaceutical products are listed. If newly registered, the upper limit will continue to fall depending on the price of the stepped drug. In the case of Donel 5m of i-World Pharm, the previous lowest price of 5mg of Donepezil, it was lowered from 1,223 won to 500 won in June through a voluntary cut. C.L.Pharm product is listed at 425 won, which is 85% of 500 won. price for Donepezil 5mg is 2,060 won, which is now about five times the difference. The industry analyzes that hospitals and clinics are receiving incentives under the drug-saving incentive system when they switch from high-priced drugs to low-priced drugs, so the lowest prices in Donepezil formulations are continuing.
- Policy
- Pediatric drugs eligible for PE exemptions from January
- by Kim, Jung-Ju Dec 01, 2022 05:46am
- Chang-Hyun Oh, Director of MOHW The government expects the ‘Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments’ that gained industry attention for increasing the scope of use of the pharmacoeconomic evaluation exemption system (PE exemption system) will be applied to drugs that apply for reimbursement in January. In other words, the government plans to confirm and apply final revisions in December. The revisions to the Health Insurance Review and Assessment Service’s guidelines are currently complete and are being reflected in the National Health Insurance Service’s detailed standards for negotiations (negotiation guidelines). After the process is complete, it will be possible to extend the application of the PE exemption system to pediatric new drugs that apply for reimbursement in January. In the case of the 200 set as the ‘small number of patients’ standard, the government reaffirmed its position that extending PE exemption to drugs for adults deviates from the purpose and priority of reimbursement while emphasizing the flexibility of the Drug Reimbursement Evaluation Committee review as it had responded at the last NA audit. Chang-Hyun Oh, Director of the Pharmaceutical Benefits Division replied so at the QA session on pending issues at a recent meeting with the multinational pharmaceutical company press on the 29th. Also, Oh drew the line and said that it was different from the government’s intentions regarding the market’s prediction that the measures will be immediately applied from November upon notice. The following is the QA script between the press corp and Director Oh. ▶After the administrative notice, HIRA has not yet publicly announced the expansion of the PE exemption system to pediatric drugs. Were there any problems in the implementation process? “We are currently changing the NHIS negotiation guidelines. The Measures to Improve Patient Access and Reinforce Reimbursement Management for High-Priced Severe Disease Treatments does not only include expanding PE exemptions to pediatric drugs. It also includes the expedited listing of severe disease treatments and expanding the scope of reference countries to A9 which is set for December 11. These revisions have to be made collectively (none of them have been publicly announced yet). We will be able to confirm and revise the plan in December. ▶The pharma and bio industry expected the measures to be implemented immediately upon notice this month (in November) and awaited HIRA’s public notification. But at the current pace, the system will be applied next year at the earliest. Is this a delay or a deferment? “Since other revisions that need to be implemented also need to be reviewed and unilaterally implemented, the measure will be applicable to drugs that apply for reimbursement from January. Since the government had not announced that it will be implemented from November, it is not a delay." ▶The industry is still strongly voicing the need to extend the PE exemptions to drugs used in adults.” “A clause ‘drugs used to treat pediatric patients that are therapeutically equivalent or has no available treatment option, and demonstrates improvement in quality of life or is otherwise approved by the committee’ has been added to HIRA’s guidelines. At the same time, ‘when the drug’s main indication is for pediatric patients’ condition has been added to NHIS’s reimbursement standard procedure improvement plan. As these two are being applied together, reimbursement will be extended to drugs whose main indication is for ‘pediatric’ patients among drugs used for both children and adults. Therefore, the extension will be applied to pediatric patients. There have been many requests for expanding the reimbursement benefit to drugs that affect adult patients. We can review it, but our current priority is in benefiting pediatric patients rather than adults.” ▶The NA and others have pointed out how the extension had rather raised the threshold for PE exemptions and reimbursement. What is the government’s opinion on this? "I have already explained the reason why the ‘small number of patients’ clause had been included at the past NA audit. The restriction was set to clarify that PE exemptions are applied when the drugs have difficulty producing evidence. DREC had answered to the National Assembly that it will deliberate reimbursements in consideration of the severity of the disease for drugs that affect a small number of patients. The same is true for the 200 range that had been set. Considering the severity of the disease, even if the number of patients exceeds 200, the drug can be considered and reviewed as a drug that affects a small number of patients. I believe DREC will make a reasonable decision."
- Company
- When will Xocova be approved in Korea?
- by Nho, Byung Chul Nov 30, 2022 05:53am
- With the new oral COVID-19 treatment Xocova starting prescriptions in Japan after obtaining emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW), attention is rising on whether it will be approved in Korea as well. In Korea, the Korea Disease Control and Prevention Agency determines the need and grants Emergency Use Authorizations to drugs after expedited review, rather than choosing among companies that submitted applications. Although no news has been heard on whether Xocova is being officially undergoing approval processes yet, news has been heard that the government will start a review, and Ildong Pharmaceutical has started preparations for Emergency Use Approval. Xocova is an oral antiviral that contains ensitrelvir that selectively inhibits the viral 3CL protease and suppresses SARS-CoV-2 replication. Xocova demonstrated clinical symptomatic efficacy through a Phase II/III trial that was conducted in Japan and Korea. Trial results showed that the mean time to initial relief of COVID-19 symptoms in patients that received Xocova was 167.9 hours, a significant reduction from the 192.2 hours in the placebo group. Xocova also met its secondary endpoint — reduction in viral RNA — in the trial. Reduction in viral RNA on day 4 following the third dose in the ensitrelvir-treated group was 1.4 log10copies/ml more than that in the placebo group. Regarding its safety, no serious adverse events or deaths have occurred from the use of ensitrelvir, and was also found to be well tolerated. Its convenience in intake has also been regarded as an advantage. Unlike conventional treatments that are administered for 5 days, twice a day, and three tablets per administration, patients only need to take Xocova once daily for 5 days as a single tablet. With the opinion that the drug has shown a positive effect in Japanese hospitals after starting prescriptions, local healthcare professionals have been welcoming the diversification of COVID-19 treatment options. The fact that Xocova can be manufactured locally in Korea if it is granted marketing authorization in Korea is also an added advantage. Ildong Pharmaceutical had previously signed an agreement with Shionogi to jointly conduct Xocova’s clinical trial. After successful development, Ildong Pharmaceutical will directly be in charge of the local manufacturing and distribution of Xocova. In other words, Xocova will be locally manufactured. However, it is true that other treatments have been previously developed and imported and the need for COVID-19 treatments is not as urgent as before. But with more than 70,000 people still being confirmed as of the 1st, and further resurgences to come, many have stressed the need to establish treatment sovereignty by securing a treatment that can be manufactured in Korea. An industry official said, “A new COVID-19 treatment option is needed as there are considerable limitations on the use of existing treatments. In particular, if we can locally manufacture a COVID-19 treatment, it will be of great support in stably supplying treatments in cases of emergency.”
- Company
- Doveprella, the first new tuberculosis drug in 50 years,
- by Eo, Yun-Ho Nov 30, 2022 05:52am
- Doveprella, a new tuberculosis drug that appeared 50 years, is expected to be listed on the insurance benefit list. According to related industries, Viatris' multidrug-resistant tuberculosis treatment Doveprella recently concluded a drug price negotiation with the NHIS. After passing the HIRA's Drug Benefit Evaluation Committee in September, the negotiation process began as soon as possible, drawing positive results. As a result, if only the Health Insurance Policy Review Committee passes, the benefit will be applied without any major problems. Doveprella, which was approved domestically in October last year after U.S. approval in September 2019, can be used as a combination of Bedaquiline and Linezolid in adult patients with extensive drug-resistant pulmonary tuberculosis, treatment intolerance, or non-reactive multidrug-resistant pulmonary tuberculosis. This drug is the first new treatment in more than 50 years. The tuberculosis treatment market has been shunned by front-line pharmaceutical companies for its poor drug economy. In fact, Doveprella is a drug created through a collaboration between Viatris and a non-profit organization called TB Alliance. Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis that is resistant to two or more tuberculosis treatments, including Isoniazid and Rifampin, which are the two most effective anti-tuberculosis drugs for the treatment of tuberculosis. The causes of the outbreak are divided into primary and acquired resistance, which is infected with tuberculosis bacteria, which are resistant from the beginning, and acquired resistance during the treatment process due to discontinuation of drug use and irregular administration. MDR-TB has only a 50% treatment success rate, so treatment efficiency is low and secondary drugs used for treatment have more side effects than primary drugs. The treatment period is also long, ranging from 18 to 24 months, so the cost is high, and in some cases, the lesion should be removed through surgery. The combined treatment of seven drugs, including Bdq, which is currently used for standard treatment of MDR-TB, is not well used in Korea due to high drug resistance, and the treatment period is still long at 9-12 months, making it difficult for patients to manage medication and high treatment failure rates. Doveprella proved its validity through a phase 3 clinical Nix-TB study. Doveprella confirmed its potential as a new short-term combination therapy, with a successful treatment effect of 92% in MDR-TB patients and 89% in a broad range of drug-resistant pulmonary tuberculosis patients in 6 months with Bedaquiline and Linezolid. The existing treatment period of 18 to 24 months was shortened to 6 months, and almost all extensive drug-resistant pulmonary tuberculosis and sputum culture-negative of MDR-TB patients were confirmed within 16 weeks. BPaL therapy was the first ready-to-use combination therapy consisting only of oral agents and showed complete data in about 90% of patients with extensively drug-resistant tuberculosis at 6 months of treatment.
- Company
- Oluminant's sales are higher than Xeljanz's
- by Kim, Jin-Gu Nov 30, 2022 05:52am
- (From left) Oluminant, Rinvoq, Xeljanz.Xeljanz lost its market lead by falling sales by 13% due to safety issues. The market for JAK inhibitors, an oral autoimmune disease treatment drug, is fluctuating. While long-time market leader Pfizer Xeljanz faltered, Lilly's Oluminant took the lead. On top of that, Abbvie Rinvoq quickly expanded its sales, signaling fierce competition. ◆↑ Olumiant 30% of sales According to IQVIA, a pharmaceutical market research firm, Oluminant's cumulative sales in the third quarter of this year were 11.7 billion won. It increased by 30% compared to the cumulative 9 billion won in the third quarter of last year. Oluminant is a drug used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. In December 2017, it was approved in Korea as the second JAK inhibitor after Xeljanz. Sales have steadily increased since November 2018 when salaries were applied as a treatment for rheumatoid arthritis. In May last year, the scope was expanded due to atopic dermatitis. In the fourth quarter of last year, it surpassed the sales of Xeljanz, an existing market-leading product. Since then, it has consistently recorded higher sales than Xeljanz. The third JAK inhibitor, Rinvoq, has a steeper growth rate. Cumulative sales in the third quarter of this year were 8 billion won, up about six times in a year from the cumulative 1.4 billion won in the third quarter of last year. Domestic permits were the latest in June 2020, compared to competing drugs, but sales have risen vertically since benefits were applied as a treatment for atopic dermatitis in May last year with Oluminant. In the third quarter of this year, quarterly sales exceeded 3 billion won for the first time. The gap with Oluminant, the No. 1 product in the market, has narrowed to 700 million won. ◆ Oluminant·Rinvoq Rising, Additional Effects of Atopic Dermatitis Indication The growth of Oluminant and Rinvoq is interpreted as a result of active indication expansion. In particular, it is analyzed that it led to sales growth by securing atopic dermatitis, which is not in Xeljanz, as an indication. Oluminant was first licensed as a treatment for rheumatoid arthritis. In May last year, atopic dermatitis was added as an indication. Oluminant is seeking to expand the indication even with hair loss. Lilly applied for the expansion of the indication with severe circular hair loss last month. Rinvoq was also approved for rheumatoid arthritis, and in October last year, additional indications for ▲ psoriatic arthritis ▲ ankylosing spondylitis ▲ atopic dermatitis were approved. Ulcerative colitis was added this year. Rinvoq currently has the most indications of JAK inhibitors. ◆ Xeljanz sales dropped 13% in a year Xeljanz's cumulative sales in the third quarter of this year were 10.2 billion won, down 13% from 11.7 billion won a year earlier. After being released in March 2015, Xeljanz expanded its influence as the only oral autoimmune disease treatment until 2018. From 2019, sales of around 4 billion won were maintained every quarter. Sales plunged 16% year-on-year in the fourth quarter of last year. Since then, it has been maintaining quarterly sales in the early 3 billion won range. It is analyzed that safety issues affected the decline in sales in the fourth quarter of last year. Based on the results of a large-scale random safety study in September last year, the U.S. Food and Drug Administration (FDA) added a black box warning, saying that JAK inhibitors, including Xeljanz, increase the risk of heart attack, stroke, cancer, and death. The Ministry of Food and Drug Safety distributed the same safety letter. In October this year, the standards were changed to be limited to patients aged 65 or older, patients in high-risk groups in ▲ the cardiovascular system, and patients at risk of ▲ malignant tumors. Pfizer plans to once again expand its influence in the JAK inhibitor market through Xeljanz's follow-up drug, Cibinqo. Like Oluminq and Rinvoq, Cibinqo is targeting atopic dermatitis. It was approved in Korea in November last year and is currently being prescribed non-reimbursed. In August, it passed the HIRA and approached the application.
