Sanofi, Regeneron's Dupixent Gets FDA Approval for COPD
WEB1 day ago · Dupixent is a key top-line driver for both Sanofi and Regeneron on strong demand trends. In the first half of 2024, Dupixent generated global product sales of $€6.1 billion, which were recorded ...
Dupixent approved in the US as the first-ever biologic medicine …
WEB4 days ago · Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay ® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com .
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB3 days ago · Sept 27 (Reuters) - The U.S. Food and Drug Administration has approved Sanofi (SASY.PA), opens new tab and Regeneron's (REGN.O), opens new tab blockbuster drug Dupixent for patients with a chronic ...
Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB3 days ago · Regeneron, Sanofi blockbuster Dupixent wins FDA approval for COPD Drug is cleared for 300,000 U.S. patients with a form of the lung disease driven by eosinophils Manage alerts for this article
Dupixent® (dupilumab) Is the First and Only Biologic to Achieve ...
WEBSep 11, 2024 · Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
Press Release: Dupixent approved in the US as the first-ever …
WEB3 days ago · Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay ® program.
INVESTORS & MEDIA - Regeneron Pharmaceuticals Inc.
WEBNov 27, 2023 · NOTUS trial met its primary endpoint with overwhelming efficacy, showing Dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence of type 2 inflammation (i.e., blood eosinophils ≥300 cells per μL), confirming results from the landmark BOREAS pivotal trial.
FDA signs off on Regeneron and Sanofi's Dupixent for COPD
WEB3 days ago · They based their figure on 30% uptake of the treatment for those who are eligible. The addition would put Dupixent’s sales potential at $20 billion by the end of this decade, making it one of ...
FDA, after delay, clears Regeneron and Sanofi drug for COPD
WEB4 days ago · European regulators approved Dupixent for COPD in July, but Regeneron and Sanofi have had to wait longer in the U.S., where the FDA requested additional efficacy data from the two trials. Over that time, a potential new competitor has emerged in GSK’s Nucala, which the FDA rejected in 2018 but earlier this month succeeded in a Phase 3 trial.
Regeneron and Sanofi Provide Update on Dupixent® …
WEBOct 20, 2023 · TARRYTOWN, N.Y. and PARIS, Oct. 20, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA) for Dupixent ® (dupilumab) in chronic spontaneous urticaria (CSU). ). CSU is an inflammatory skin condition ...