Dupixent approved in the US as the first-ever biologic medicine …
WEB4 days ago · 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, and also showed improvements in lung function and health-related quality of life ...
Dupixent® (dupilumab) Approved in the U.S. as the First-ever
WEB3 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 ...
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 ...
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, 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.
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
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® - Pivotal Trial Results | Sanofi
WEBMar 23, 2006 · Dupixent® demonstrates potential to become first biologic to treat COPD by showing significant reduction in exacerbations in pivotal trial. First and only biologic to demonstrate clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo.
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 · In some patients with chronic obstructive pulmonary disease (COPD), type 2 inflammation may increase exacerbation risk and may be indicated by elevated blood eosinophil counts. Dupilumab, a fully...