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- 2026-05-08 20:04:12
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- JW Pharm to discuss technical partnerships for its gout Tx
- by Lee, Seok-Jun Dec 22, 2021 05:56am
- JW Pharmaceutical will be discussing technical partnerships for its key new drug candidates such as URC102 and JW2286 with global pharmaceutical companies. On the 20th, JW Pharmaceutical announced that it will be attending the ‘2022 JP Morgan Healthcare Conference’ that will be held online from the 10th next month (local time) and introduce its research projects to overseas pharmaceutical companies and global investors and conduct one-on-one virtual partnership consultations. The company plans to discuss tech partnerships for its self-developed innovative drug candidates at the conference. For example, the company will be promoting the technology export of its gout treatment URC102 to the global market, other than China. JW Pharmaceutical had signed a technology transfer agreement for URC102 with a Chinese company, Simcere Pharmaceutical, in 2019. The safety and efficacy of URC102 were demonstrated through a Phase 2b clinical trial that was completed in March. The company had also started a clinical trial to extend the eligibility of the drug to patients with nephropathies. A Phase III trial on these subjects is expected to start next year. Also, the company will promote technology partnerships for its STAT3-targeted anticancer drug, JW2286. JW2286 inhibits STAT3 and is indicated for the treatment of solid tumors, such as triple-negative breast cancer, gastric cancer, colorectal cancer, etc. The company is conducting nonclinical studies and drug manufacturing research to initiate clinical trials. STAT3 is a protein that promotes the expression of multiple genes. The abnormal activation of STAT3 causes tumor cell growth, proliferation, metastasis, and drug tolerance, but none had succeeded in developing anticancer drugs targeting STAT3 so far. Also, JW Pharmaceuticals will share its latest research and clinical development strategies on JW0061, a new drug candidate for hair loss that differentiates and promotes hair follicle stem cells involved in hair formation by activating the Wnt signaling pathway that regulates cell proliferation and regeneration, and JW1601, a drug that is extending its indication to age-related macular degeneration and ophthalmologic diseases such as allergic conjunctivitis, etc.. Around 1,500 pharmaceutical and bio companies from 50 countries attend the JP Morgan Healthcare Conference every year. Companies attend the conference to introduce their pipelines and technology to global healthcare companies. Also, participating companies are provided with an opportunity to meet with funds like venture capitals, hedge funds, PFEs, etc.
- Company
- "MET-targeted therapy as a new personalized NSCLC solution"
- by Eo, Yun-Ho Dec 21, 2021 06:05am
- Professor Ji-Youn Han HER2, ALK, EGFR, ROS1, NTRK. These keywords have been frequent visitors in articles on anticancer drugs recently. With the discovery that effective anticancer treatments differ depending on the patient’s genetic mutation status, personalized treatments that target specific genes of each individual are being introduced. And the development of precision medicine has heralded the paradigm shift of cancer treatments to ‘gene-specific treatment’ from ‘diseases-specific treatment.’ Amid rising expectations, the first anticancer treatment that targets the MET gene was newly introduced to Korea. The treatment, Novartis’ ‘Tabrecta (capmatinib),’ was authorized for the treatment of metastatic non-small cell lung cancer (NSCLC) with MET exon 14 deletions. The new introduction of an option in this rare type that occurs in approximately 3-4% of patients with NSCLC is gaining much attention in the medical community. Dailypharm met with Ji-Youn Han, Professor of Hemato-oncology at the National Cancer Center to hear about the use and potential of MET-targeted anticancer therapies and personalized treatment that has been implemented but is yet unfamiliar to the general public. - A treatment that targets the MET mutation has landed in Korea. What significance does the introduction of this new drug bring to the lung cancer treatment paradigm? The MET exon 14 skipping mutation is very rare in lung cancer. Various clinical trials have confirmed that exon 14 skipping mutation is an oncogenic driver mutation of lung cancer. Also, patients who have MET amplification or overexpression have very poor prognoses. In this sense, the approval of Tabrecta, a treatment that demonstrated clear efficacy in MET exon 14 skipping mutation, holds great significance as the prompt introduction of MET inhibitors has become ever important. - Not many patients may be eligible to use the drug. How many will be eligible, in Korea and what other characteristics do eligible patients have? In the West, patients with MET exon 14 skipping mutations account for approximately 3% of all NSCLC patients, In Korea, the reported rate is around 2-3%. One clinical feature of the disease is that it occurs more often in elder patients than younger patients. According to clinical studies, the median age of patients was around 70. -How is the MET diagnosis environment in Korea? Several hospitals have brought in NGS testing devices after NGS-based gene panel tests were applied selective reimbursement in 2017. The MET gene is an important oncogenic driver gene that is included in most NGS panels. However, identification of MET exon 14 skipping mutation is diagnostically difficult and requires further considerations. Also, by genetic mutations, some are more fit for RNA-based NGS tests rather than DNA-based NGS tests. In particular, identifying MET exon 14 skipping mutation through a DNA-based NGS test requires further detailed diagnosis to identify hundreds of mutations that can cause exon 14 skipping mutations. On the other hand, as an RNA-based NGS test can easily discern exon 14 skipping mutations, the RNA-based NGS test may be needed to identify exon 14 skipping mutations. But in practice, RNA-based tests are used less than DNA-based tests. - Commercialization of other MET inhibitors like tepotinib is also imminent. The MET inhibitor tepotinib had differentiated patients according to treatment experience in its clinical design. According to the Phase II GEOMETRY mono-1 trial, patients who used Tabrecta as first-line had shown higher objective response rates (ORR). On the other hand, the response rate was similar in patients using tepotinib regardless of treatment history. The efficacy and safety of the two were comparable in clinical trials. The IC50 value of the two drugs that determine how much of a drug is needed to inhibit cell growth by 50%, was slightly better for Tabrecta. However, most anticancer drugs are best effective in the subject patients when prescribed at the earliest. In particular, not all patients with MET exon 14 skipping mutations who have high PD-L1 expression respond to immunotherapy treatment. Using a combination of immunotherapy-chemotherapy as first-line can increase the financial burden borne by the patients and even be less effective than Tabrecta. This is why some advanced countries like Canada believe it is necessary to thoroughly check for MET exon 14 skipping mutations by using biopsy as well as liquid biopsies in order to reduce patient burden. -Also, studies on the combined use of MET inhibitors and EGFR TKIs are also active. In particular, there are expectations that the MET inhibitors may resolve the resistance issue of 3rd generation EGFR TKIs. Around 10% of the EGFR mutated lung cancers occur due to METs. This is why a smart MET inhibitor partner may be needed to address the acquired resistance to EGFR TKI. There had been a clinical trial that tested the combined use of Tabrecta and EGFR TKI. As it is unclear which causes EGFR mutations in lung cancer - MET amplification or overexpression – the study enrolled both patients. In the trial, a patient with EGFR exon 19 deletion mutation who have experienced primary resistance participated in the trial and reached complete remission (CR). One thing to note is that we do not need to only use 3rd generation EGFR TKIs like ‘Tagrisso (osimertinib)’ when attempting combination therapies. Not only because of the price, but I believe that 1st and 2nd generation EGFR TKIs can also be sufficient partners. Also, a study on Tabrecta+Tagrisso in patients with EGFR resistance is in progress, which medical institutions in Korea are also planning to participate in.
- Company
- Is there a shortage of chickenpox vaccines?
- by Moon, sung-ho Dec 21, 2021 06:05am
- Contrary to the opinions of the medical community, SK Bio and GC Pharma said, "There is no problem in supplying chickenpox vaccines." The shortage of influenza (flu) vaccines in the second half of this year is causing confusion due to concerns that chickenpox vaccines may also be insufficient. Pharmaceutical and bio companies that produce chickenpox vaccines say there is no problem with supply, but there are already opinions that they should prepare for the shortage of vaccines at medical sites centered on related societies. According to the medical and pharmaceutical industries on the 25th, GC Pharma's "Barycela" is currently available for vaccination. There are 'Vari-L Vaccine' by Boranpharma and Sky Varicella by SK Bioscience. Among them, as the government recently declared "With Corona", there are opinions concerned about the increase in the number of people with infectious diseases such as flu and chickenpox at the medical site. Professor Eom Joong-sik (Infectious Medicine) at Gil Hospital said, "According to related data, infectious medicine doctors believe that the rate of wearing masks has definitely fallen. Considering that the flu and chickenpox are often occurring, the amount of contact is increasing." Accordingly, medical scientists and societies are concerned about the shortage of chickenpox vaccines and are preparing for the possible shortage of vaccines through changes in vaccination guidelines internally. There is a sense of crisis due to the fact that they already experienced a shortage of flu vaccines in the second half of the year. Currently, the government is vaccinating chickenpox vaccines free of charge for infants 12 to 15 months old. A KAPID executive said, "GC Pharma has stopped supplying chickenpox boxes and the launch of a next-generation vaccine, an alternative item, is also being delayed. It was originally scheduled to be released last year, but it was postponed to early this year, but we haven't heard of the release plan yet. As a result, we believe there is a possibility that the launch will be delayed further, he hinted. Another KAPID executive said, "In the case of chickenpox, if there is a shortage of vaccines, we are internally sharing the opinion that new, that is, initial vaccinations should be delayed and patients subject to secondary vaccinations should be vaccinated first." He then said, "It hasn't happened yet, so we're preparing for now." He said, "It would be fortunate if SK Bioscience, which accounts for the largest volume, supplies it normally." Pharmaceutical and bio companies that are supplying chickenpox vaccines to Korea say there is no problem at the moment. They say they are overly concerned at the clinical site. GC Pharma explains that it can supply its new product Barycela in earnest from the second half of this year, replacing Suduvax, which has decided to suspend supply. It is true that the plan to start supply in January this year after obtaining product approval in March last year has been delayed due to problems such as prolonged Corona and delayed NIP registration, but it has entered the normalization stage from the second half of the year. An official from GC Pharma said, "After deciding to stop supplying Suduvax, we will be able to supply Barycela, which was developed as a next-generation vaccine, without any problems. As a result of internal confirmation, we believe that the supply is going well enough." SK Bioscience, which accounts for the largest portion of the domestic chickenpox vaccine supply, is in a position that there will be no problem in supplying vaccines like GC Pharma. An official from SK Bioscience said, "As of the third quarter, Sky Varicella's share among chickenpox vaccines in Korea was 43%," and emphasized, "In the case of flu vaccines, there were some difficulties in producing and supplying chickenpox vaccines."
- Company
- Losartan products are about to be withdrawn from the market
- by Kim, Jin-Gu Dec 20, 2021 06:12am
- With the recovery of Losartan with excessively detected impurities, pharmaceutical companies are considering strategies after recovery measures are completed. Many pharmaceutical companies that did not have a very high market share in the Losartan market are reportedly considering gradually withdrawing from the market after the recovery is completed. It is predicted that the pace of market reorganization will accelerate after the recovery measures are completed. According to the pharmaceutical industry on the 20th, a large Korean pharmaceutical company A is discussing ways to stop selling the product line after the recovery of Losartan is completed. Company A has five Losartan items, and some or all of these products are subject to collection. According to UBIST, a pharmaceutical market research firm, the amount of outpatient prescriptions for company A's five Losartan items last year was more than 7 billion won. It is confirmed that more than 5 billion won was prescribed cumulatively by the third quarter of this year. The pharmaceutical industry interprets the reason why Company A is considering withdrawing the market as to resolve uncertainties. Since NDMA impurities were first discovered in Valsartan in 2018, the pharmaceutical industry has struggled with the impurity crisis every year. In particular, since all impurity incidents occurred in unexpected situations, it was difficult for companies as sales suspension and recovery were repeated after detecting impurities. Moreover, in the case of Company A, it is considered the background of considering withdrawal from the market since it has various ARB drugs such as Telmisartan, Candesartan, Valsartan and and Irbesartan. An official from Company A said, "Nothing has been accurately decided yet. Losartan's prescription performance is not bad, but other ARB-based drugs are larger in terms of the total amount of prescription," he said. The pharmaceutical industry predicts that pharmaceutical companies, including Company A, will withdraw from the market after the recovery of the Losartan hypertension treatment is completed. As of last year, the amount of outpatient prescriptions in the hypertension treatment market, including Losartan, was 320.8 billion won, with two companies, Hanmi and Organon accounting for more than half (53.9%). Hanmi's five types of Losartan recorded 122.4 billion won in prescriptions last year, accounting for 38.1% of the market share. Organon accounts for 15.8%. It was followed by 3.9% per Chong Kun Dang, 3.0% of SK Chemicals, 2.9% of Samik, 2.4% of Kyung Dong, 2.2% of HK inno.N, and 2.0% of Daewoong Bio. In addition, 91 companies are competing for the remaining 27.5%. Most pharmaceutical companies' annual prescriptions are less than 500 million won. The MFDS announced on the 7th that all or some manufacturing number products of 295 items from 98 companies that were detected or feared to exceed the daily intake allowance will be voluntarily recovered. The pharmaceutical industry is in the process of recovering the product.
- Company
- EMA designated Hanmi's HM15211 as ODD
- by Kim, Jin-Gu Dec 20, 2021 06:12am
- Hanmi Pharmaceutical's LAPSTriple Agonist, HM15211 announced on the 17th that it has been designated as ODD by the European Medicines Agency (EMA). According to Hanmi Pharmaceutical, EMA recently designated it as ODD for the treatment of primary sclerosing cholangitis, PSC. The LAPSTriple Agonist has previously been designated as ODD by the FDA. It was designated as a rare drug in March last year, and was once again designated as ODD in May this year. With this designation, LAPSTriple Agonist has become a new drug that has received a total of four rare drug designations, including three from the FDA and one from the EMA. Including this, Hanmi Pharmaceutical will hold a total of 18 ODD designated records (9 FDA cases, 6 EMA cases, and 3 MFDS cases) with 10 indications from 6 pipelines. At this point, it is the highest record among domestic pharmaceutical companies. LAPSTriple Agonist is a triple agonist that acts as a simultaneous activation of GLP-1 receptors, glucagon receptors, and GIP receptors. Based on multiple pharmacological effects, it is expected that excessive accumulation of bile acids in the liver will be reduced and liver inflammation and fibrosis will be suppressed to dramatically improve the quality of life of patients. Hanmi Pharmaceutical confirmed the effects of LAPSTriple Agonist on reducing bile acid accumulation and anti-inflammatory and anti-fibrotic effects. Primary sclerosing cholangitis is a chronic progressive bile identity liver disease caused by unknown intrahepatic biliary tract inflammation and fibrosis. The FDA and the EMA's designation of ODD is a system that supports the smooth development and permission of treatments for rare and intractable diseases or life-threatening diseases. In Europe, the cost of applying for permission will be reduced, and various benefits such as exclusive rights for 10 years will be granted when approving the first marketing permit among products of the same affiliate.
- Company
- Myung In’s Parkinson’s Tx demonstrates efficacy
- by Dec 20, 2021 06:12am
- A Parkinson’s disease treatment that Myung In Pharm has acquired an exclusive licensing agreement from an Israeli pharmaceutical company - 'P2B001 (Fixed-dose combination of pramipexole+rasagiline)’ – has demonstrated its safety and efficacy at a global Phase III clinical trial. According to the topline results announced by the Israeli pharmaceutical company Pharma Two B Ltd. (P2B), P2B001 successfully met its primary and key secondary endpoints and demonstrated statistically significant benefit over existing treatments. A total of 544 patients with early-stage Parkinson's disease in 70 centers in the US, Europe, and Canada were randomized to four treatment arms: P2B001 (pramipexole 0.6mg + rasagiline 0.75mg combination); pramipexole ER capsule (pramipexole 0.6 mg); rasagiline ER capsule (rasagiline 0.75mg); and the currently marketed pramipexole ER capsules titrated to an optimal dose for each individual. Patients in each treatment arm were administered their respective dose once a day for 12 weeks. The primary endpoint was the change in the total Unified Parkinson's Disease Rating Scale (UPDRS, defined as the sum of parts II and III) for P2B001 as compared to each of its components over 12 weeks. Results showed that P2B001 improved the total UPDRS score by 2.66 points compared to the pramipexole 0.6mg-treated arm (p=0.0018) and by 3.30 points compared to the rasagiline-treated arm (p=0.0001). Also, P2B001 showed significant improvement over its comparators in the secondary endpoint, Epworth Sleepiness Scale (ESS) score. From a safety prospect, P2B001 significantly reduced adverse events including sleepiness and orthostatic hypotension compared to the pramipexole ER capsule. The company explained that the trial results support the use of P2B001 as first-line treatment in patients with early-stage Parkinson's disease, once a day, without the need for titration. Hang Myung Lee, CEO/President of Myung In Pharm, said, “With the Phase III clinical trial results, we have now secured data that P2B001 has superior efficacy and a more significant safety profile over each of its individual components as well as the currently marketed pramipexole ER capsules. We believe that P2B001 could become an important new option when considering the long-term care plan that needs to be set for early-stage Parkinson's disease and the superior efficacy demonstrated in the trial.” P2B plans to submit a New Drug Application to the FDA next year. Myung In Pharm also plans to apply for marketing authorization of P2B001 to the Ministry of Food and Drug Safety in 2022 and release the drug in Korea in 2023. Myung In Pharm had acquired the exclusive license for the commercialization of P2B001 in Korea through an equity investment in P2B in November this year.
- Company
- Expectations rise for Lilly’s Alzheimer drug
- by Eo, Yun-Ho Dec 20, 2021 06:11am
- Expectations have been rising for the commercialization of Lilly’s new drug candidate for Alzheimer’s. On the 15th (local time), Eli Lilly announced that it will complete filing for approval of its new Alzheimer’s candidate ‘donanemab’ within the first quarter of 2022. The news was announced at an investor meeting while introducing plans for five new drugs that will be launched within the next two years. Lilly had previously said that an application for approval of donanemab would be made sometime next year. if Lilly’s donanemab is approved, the addition of donanemab to the market following Biogen’s accelerated approval of Aduhelm in June is expected to intensify competition. Although the information available on donanemab is limited, a head-to-head study against Aduhelm is ongoing, and initial data from the study is expected to roll out in the second half of next year. Based on the initial data from a Phase II trial announced earlier this year, the FDA granted Breakthrough Therapy designation for donanemab in June. Results of Lilly’s Phase II TRAILBLAZER-ALZ trial on donanemab is a monoclonal antibody that targets a modified form of beta-amyloid called N3pG that was released in July demonstrated that the reduced beta-amyloid deposits slowed the decline of cognitive function in Alzheimer patients. Donanemab Patients with early symptoms of Alzheimer’s who were administered donanemab in the trial showed a rapid reduction in amyloid plaque at 24 weeks and showed the most rapid amyloid plaque removal in patients who had the most severe plaque burden at baseline. At the meeting, Lilly also announced its release plans for its antidiabetic tirzepatide, mantle cell lymphoma treatment pirtobrutinib, ulcerative colitis treatment mirikizumab, and atopic dermatitis treatment lebrikizumab.
- Company
- Ildong signed for Nexium worth ₩50 billion
- by Dec 20, 2021 06:11am
- AstraZeneca Korea announced on the 14th that it has signed a partnership contract with Ildong for gastroesophageal reflux disease treatment "Nexium (Esomeprazole)" and type 2 diabetes treatment "Qtern (Dapagliflozin/Saxagliptin Monohydrate)." Through this, Ildong Pharmaceutical will jointly sell Nexium and Qtern with AstraZeneca Korea from January 1 next year. In 2014, the two companies promoted Onglyza and Komblyze XR (Metformin HCl/Saxaglipin Monohydrate). Ildong Pharmaceutical has succeeded in marketing H2 receptor antagonists, PPI drugs, and functional dyspepsia treatments. Ildong Pharmaceutical plans to grow Nexium into an item with annual sales of more than 50 billion won in the future. Last year, Nexium's domestic sales were estimated at about 49.4 billion won. Nexium was jointly sold by Daewoong Pharmaceutical, and the contract ends on December 31. Daewoong Pharmaceutical plans to focus on selling its own P-CAB-based gastroesophageal reflux disease treatments Fexuprazan and Nexium. Kim Sang-pyo, CEO of AstraZeneca Korea, said, "We are happy that the two companies, which have been maximizing each other's strengths in the diabetes treatment field for the past eight years, are seeking opportunities for a new leap forward in the digestive field." He said, "We hope to provide differentiated treatment benefits of 'Nexium' and 'Qtern' to more medical staff and patients." Yoon Woong-seop, vice chairman of Ildong Pharmaceutical, said, "We are looking forward to strengthening our partnership with AstraZeneca Korea through Nexium and Qtern following Onglyza and Kombiglyze XR." He said, "We plan to do our best not only for the health of patients but also for the smooth medical activities of medical staff, but also to create synergy between the two companies and expand market performance."
- Company
- New depression drug Spravato lands in the 'Big 5' Hospitals
- by Eo, Yun-Ho Dec 16, 2021 05:52am
- Janssen’s new drug for depression, ‘Spravato,’ can now be prescribed at general hospitals in Korea. According to industry sources, Spravato (esketamine) that is used in combination with an oral antidepressant, has passed the review of drug committees (DC) of 80 medical institutions in the nation including the 'Big-5' general hospitals - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St. Mary’s Hospital, and Severance Hospital - as well as the Kyung Hee University Medical Center, Kyungpook National University Hospital, Inje University Paik Hospital, Seoul National University Bundang Hospital, Chung-Ang University Hospital, Jeju National University Hospital, Inje University Haeundae Paik Hospital. Spravato, which was approved in June last year in Korea, was the first-ever prescription nasal spray with a new mechanism of action that was introduced in the field of treatment-resistant depression (TRD) and the first in 30 years introduced in the field of major depressive disorder. Spravato’s esketamine modulates the glutamate receptor called an N-methyl D-aspartate (NMDA) receptor in the brain and restores synaptic function and increases neurotrophic signaling to improve depression symptoms. Last year, the drug added an indication for the treatment of major depressive disorder with suicidal thoughts or actions. The approval of the depression with suicidal ideation indication was based on results of the global Phase III ASPIRE I and ASPIRE II study. In both ASPIRE I and ASPIRE II, Spravato met the primary endpoint as defined as the reduction in depressive symptoms from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) at 24 hours after the first dose when taken in conjunction with standard of care therapy (including oral antidepressants and hospitalization). Efficacy for the initial indication of treatment-resistant depression was demonstrated through a Phase 3 clinical trial consisting of short- and long-term trials that were conducted on 1,700 adult patients with treatment-resistant depression. In the short-term clinical trial on patients aged 18 to 65 years with treatment-resistant depression, the MADRS score of patients who were administered Spravato in combination with oral antidepressants was lowered by 19.8 points during the 4-week treatment period. Patients who were administered a placebo showed a 15.8 point reduction in the MADRS score, demonstrating a statistically significant improvement in symptoms of patients who used Spravato with an oral antidepressant. In the long-term trial, the probability of recurrent depressive symptoms was 51% percent lower in the Spravato +oral antidepressant-treated group that achieved stable remission than that of the placebo+oral antidepressant-treated group. Jong-woo Paik, Professor of Mental Health and Medicine at Kyunghee University, said, “Unlike other antidepressants that take several days for symptoms to improve after intake, Spravato showed immediate improvement in depressive symptoms. Such a characteristic is particularly effective in treating and managing patients in emergencies such as those who had attempted suicides.”
- Company
- Dupixent can be used by all age groups
- by Dec 16, 2021 05:51am
- Dupixent, atopic dermatitis (Eczema) treatment that marks its third anniversary, is becoming the only biological agent available for all ages. Doctors agreed, "It is time to show flexibility in applying Dupixent benefits that have secured long-term effectiveness and safety." At an online seminar held by Sanofi to mark the 3rd anniversary of its launch in Korea on the 13th, Ahn Ji-young, a dermatologist at the National Medical Center, and Na Chan-ho, a dermatologist at Chosun University Hospital, shared their long-term Dupixent administration experience in 52 weeks (1 year) in domestic adult atopic dermatitis patients. Professor Ahn's 52-week long-term data is a study that analyzed the medical records of patients treated with Dupixent from September 2018 to December 2020, targeting 99 adult patients with moderate-severe symptoms. In the 52nd week of administration, EASI improved 88.1% compared to 30.02 points in the baseline. 89.9% of the administered group achieved EASI-75, and the itching NRS score also improved by 76.6% compared to the baseline of 8.37 points. The POEM score also improved 67.21% compared to the baseline (23.73 points) in week 52, and DLQI improved 69.02% compared to the baseline (22.37 points). Even in long-term administration for 52 weeks, it was consistent with the safety profile shown in phase 3 clinical trials. The main adverse reactions improved as both symptoms were treated, including facial erythema (19.9%) and conjunctivitis (17.17%). Professor Ahn said, "Atopic dermatitis is a chronic disease, and long-term symptom improvement requires safe and continuous treatment," and added, "Dupixent was able to confirm the long-term effectiveness and safety profile up to 52 weeks consistent with clinical trials in domestic patients." Professor Na then announced the results of an analysis of moderate-severe youth patients treated with Dupixent for one year from October last year. He explains that children and adolescents suffering from severe atopic dermatitis are burdened with serious diseases such as study, sleep, and outdoor activities. Until Dupixent received indications for children and adolescents, treatment options such as systemic immunosuppressants were limited. Dupixent improved the EASI score by 82.9% compared to the baseline (25.1 points) in the 16th week of administration, and the CDLQI related to childhood skin also increased by 57.2% compared to the baseline (13.1 points). POEM scores and itching NRS scores improved 54.4% and 53%, respectively, compared to baseline. Like adults, it showed similar effects in domestic youth patients in the actual clinical environment. Furthermore, the EASI-75 achievement rate was 77.8%, which was better than that of phase 3 (41.5%). Recently, Sanofi also confirmed the effectiveness and safety of Dupixent in phase 3 clinical trials for infants and toddlers aged 6 months to 5 years. If the indications expand to that age, Dupixent is expected to be the only biological agent available to patients of all ages suffering from moderate-severe atopic dermatitis. Experts said it was time to give flexibility to Dupixent's conditions, which secured a variety of data. Professor Ahn said, "It is necessary to study whether patients undergoing long-term administration maintain their effectiveness even if the administration interval is increased. At the same time, it would be nice to expand benefits to patients who are initially administered by reflecting subjective indicators in addition to objective indicators, she said. Professor Na also added, "As the guidelines of the Association of Atopic Dermatitis have recently been revised to reflect subjective indicators such as DLQI, it seems necessary to refer to the standards."
