On February 16, Sanofi/Regeneron announcedJapan's Ministry of Health, Labour and Welfare (HLW) approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (CSU) in patients aged 12 years and older whose condition is not adequately controlled by existing therapies.Japan is the first country to approve Dupixent for the treatment of CSU.。The approval in Japan was mainly based on the data from Study A of the LIBERTY-CUPID clinical trial program. Study A evaluated the efficacy and safety of dupilumab as an add-on therapy to standard antihistamines compared with antihistamines alone in 138 patients aged 6 years and older with chronic spontaneous urticaria (CSU). These patients continued to experience symptoms despite the use of antihistamines and had not previously received omalizumab treatment.Sanofi announced positive results from Study A on July 29, 2021. The trial met its primary endpoint and all key secondary endpoints at 24 weeks. For biologic-naïve patients, treatment with dupilumab in combination with standard-of-care antihistamines significantly reduced itch and hives symptoms compared to treatment with antihistamines (placebo) alone.DupilumabThe safety of monoclonal antibodies in CSU is generally consistent with the known safety in other approved dermatological indications.As early as October last year, the US FDA had issuedFull Response Letter(CRL). The CRL indicated that additional efficacy data is required to support approval. Regeneron stated that an ongoing clinical trial (Study C) will continue to recruit patients, with results expected by the end of 2024, which will provide additional efficacy data.As the ace product in Sanofi's autoimmune pipeline, the revenue of Praluent reached a new high in 2023, achieving€10.715 billion (approximately $11.717 billion, +34%), successfully breaking through the 10 billion US dollar mark.This is due to the continuous release of clinical needs for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and eosinophilic esophagitis (EoE).
The recent successful approval of a new indication in Japan, coupled with the anticipated approval of the COPD indication later this year, will provide significant momentum.DupilumabMonoclonal antibody revenue hits new high.Sanofi CEO Paul Hudson also stated that Dupilumab's 2024Annual sales will reach 13 billion euros.Copyright © 2024 PHARMCUBE. All Rights Reserved.Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article.For reprint, please leave a message to the WeChat Official Account backstage or send a message, and indicate the name and ID of the official account.Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.
