Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB9 hours ago · Dupixent, commonly used to treat eczema and asthma, was cleared for a subset of patients with chronic obstructive pulmonary disease.
Dupixent approved in the US as the first-ever biologic medicine …
WEB23 hours ago · 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 patients.
FDA signs off on Regeneron and Sanofi's Dupixent for COPD
WEB9 hours ago · The FDA has expanded the label of Regeneron and Sanofi's Dupixent to treat COPD. Dupixent becomes the first biologic for COPD patients in the U.S.
FDA, after delay, clears Regeneron and Sanofi drug for COPD
WEB23 hours ago · FDA, after delay, clears Regeneron and Sanofi drug for COPD Dupixent is the first biologic medicine approved in the U.S. for the common lung condition, though competitors from GSK, AstraZeneca and Roche could follow.
FDA Approves Dupilumab as First Biologic Treatment for COPD
WEB8 hours ago · The FDA approved dupilumab (Dupixent; Regeneron/Sanofi) today for treating patients with uncontrolled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. 1. This approval ...
Press Release: Dupixent approved in the US as the first-ever
WEBSep 27, 2013 · 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 patients. Jean Wright, M.D.
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® - 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.
WEBMay 21, 2023 · 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 the investigation of two potentially first-in-class biologics, Dupixent and itepekimab.
Dupixent® (dupilumab) Demonstrates Potential to Become First …
WEBMar 23, 2023 · The randomized, Phase 3, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in 939 adults who were current or former smokers aged 40 to 80 years with moderate-to-severe COPD. All patients in the trial had evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells/µL.
- Some results have been removed