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 · Paris and Tarrytown, NY, September 27, 2024. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US to treat these ...
Dupixent approved in US for adults with poorly controlled COPD
WEB14 hours 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, …
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB3 days ago · Sanofi last year recorded a combined 10.72 billion euros ($11.94 billion) in sales for Dupixent, which is already used to treat immune system-related conditions such as asthma and eczema in the U ...
Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB3 days ago · Sept. 27, 2024. West Coast Biotech & Life Sciences Reporter. Dupixent is already a blockbuster therapy for a range of immune-mediated diseases, but the Food and Drug Administration’s approval of ...
FDA greenlights Regeneron’s Dupixent for the treatment of COPD
WEB3 days ago · Treatment with Dupixent was shown to reduce COPD exacerbations by 30% in the BOREAS trial and by 34% in the NOTUS trial over 52 weeks. Additionally, the biologic was associated with improvements ...
Press Release: Dupixent approved in the US as the first-ever …
WEB3 days ago · Dupixent approved in the US as the first-ever biologic medicine for patients with COPD Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an ...
Dupixent® (dupilumab) Is the First and Only Biologic to Achieve ...
WEBSep 11, 2024 · Dupixent® (dupilumab) Is the First and Only Biologic to Achieve Significant Improvements in Disease Remission and Symptoms in Bullous Pemphigoid (BP) Positive Pivotal Trial. Trial met the primary and all key secondary endpoints in adults with moderate-to-severe disease; five times more patients achieved sustained disease remission with ...
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.
US FDA approves Sanofi-Regeneron's Dupixent for 'smoker's …
WEBSanofi recorded 10.72 billion euros ($11.94 billion) in sales for Dupixent in 2023, which includes Regeneron's share. Analysts on average expect Dupixent, by far Sanofi's best-selling drug, to ...