FDA approves Dupixent for chronic obstructive pulmonary disease
WEB1 day ago · The U.S. Food and Drug Administration has approved Regeneron's Dupixent (dupilumab) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease ...
Dupixent Gets FDA Approval for COPD - WebMD
WEB1 day ago · With the new use, Dupixent becomes the first biologic treatment for COPD in the U.S. COPD is a long-term lung disease that makes breathing difficult and gets worse over time.
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.”.
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 eosinophilic phenotype Following recent approvals in the EU and China, the US approval is based on two landmark phase 3 studies that showed Dupixent achieved significant reduction in exacerbations ...
Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 ...
WEBMay 20, 2024 · In patients with COPD and type 2 inflammation as indicated by elevated blood eosinophil counts, dupilumab was associated with fewer exacerbations and better lung function than placebo.
Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD …
WEBMay 20, 2024 · NOTUS results confirm landmark data from the phase 3 BOREAS study and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation. Data support the potential of …
Update on FDA Priority Review of Dupixent® (dupilumab) for the ...
WEBMay 31, 2024 · The primary endpoint was met in both trials, showing Dupixent significantly reduced annualized moderate or severe acute COPD exacerbations by up to 34%, compared to placebo. Dupixent rapidly and significantly improved lung function compared to placebo, with improvements sustained at 52 weeks.
Dupilumab for COPD with Type 2 Inflammation Indicated by …
WEBMay 21, 2023 · Among patients with COPD who had type 2 inflammation as indicated by elevated blood eosinophil counts, those who received dupilumab had fewer exacerbations, better lung function and quality of...
Dupixent approved in US for adults with poorly controlled COPD
WEB3 days ago · The FDA has approved Dupixent as an add-on maintenance treatment for adults with poorly controlled COPD and high counts of immune cells.
Sanofi, Regeneron's Dupixent Gets FDA Approval for COPD
WEB3 days ago · Sanofi and Regeneron's Dupixent becomes the first biologic treatment approved for COPD in the United States.