Dupixent approved in the US as the first-ever biologic medicine …
WEB6 days ago · With today’s approval, Dupixent once again paves the way and becomes the first and only approved add-on biologic medicine for inadequately controlled COPD, giving patients living with this devastating disease the chance to look forward to the potential of improved breathing and a life with fewer exacerbations.”.
Sanofi, Regeneron's Dupixent Gets FDA Approval for COPD
WEB3 days ago · Dupixent was also approved for the COPD indication in China last week. Sanofi’s stock has gained 16.0% so far this year compared with an increase of 20.2% for the large cap pharmaceutical industry.
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB5 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 ...
Dupixent Approved as Add-On Maintenance Therapy in COPD
WEB1 day ago · The Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance therapy for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.. The approval was supported by data from the randomized, double-blind, multicenter, parallel-group, placebo-controlled, phase 3 trials BOREAS (ClinicalTrials.gov Identifier ...
FDA Approves Dupixent for Chronic Obstructive Pulmonary Disease
WEB1 day ago · TUESDAY, Oct. 1, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. The approval was based on results from two pivotal phase 3 trials (BOREAS and ...
Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB5 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 ...
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 ...
Press Release: Dupixent approved in the US as the first-ever …
WEB5 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 ...
FDA greenlights Regeneron’s Dupixent for the treatment of COPD
WEB5 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 ...
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEBIt has anticipated steeper growth in Dupixent sales in 2025 after the launch for COPD in the country. Analysts on average expect Dupixent, by far Sanofi's best-selling drug, to generate more than ...