Dupixent® (dupilumab) Approved in the U.S. as the First-ever …
WEB4 days ago · Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung ...
FDA signs off on Regeneron and Sanofi's Dupixent for COPD
WEB4 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 ...
Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB4 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) Significantly Reduced COPD …
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.
Dupixent® (dupilumab) Approved in the U.S. as the First-ever
WEB4 days ago · Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent ...
Update on FDA Priority Review of Dupixent® (dupilumab) for the ...
WEBMay 31, 2024 · Regeneron and Sanofi are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation, and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB4 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 ...
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 US for adults with poorly controlled COPD
WEB1 day ago · The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with poorly controlled chronic obstructive pulmonary disease (COPD) and high counts of immune cells called eosinophils. Elevated eosinophils are a marker of type 2 inflammation, …
Press Release: Dupixent approved in the US as the first-ever …
WEB4 days ago · Sanofi and Regeneron are motivated to transform the treatment paradigm of COPD by examining the role different types of inflammation play in the disease progression through Dupixent, a first-in ...