Dupixent Gets FDA Approval for COPD - WebMD
WEB2 days ago · Oct. 2, 2024 — The FDA has approved Regeneron and Sanofi’s drug Dupixent for patients with COPD (chronic obstructive pulmonary disease). Marking the sixth indication for the drug, the approval ...
Dupixent approved in the US as the first-ever biologic medicine …
WEBSep 27, 2024 · 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 Approved as Add-On Maintenance Therapy in COPD
WEB3 days 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 ...
Dupixent approved in US for adults with poorly controlled COPD
WEB5 days 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, …
Dupixent Approved as Add-On Maintenance Therapy in COPD
WEB3 days ago · Dupixent ® (dupilumab) approved in the US as the first-ever biologic medicine for patients with COPD. News release. News release. Regeneron Pharmaceuticals, Inc. Accessed September 27, 2024.
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
Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 ...
WEBMay 20, 2024 · We designed the NOTUS trial to confirm the efficacy and safety of dupilumab in patients with COPD and evidence of type 2 inflammation indicated by blood eosinophil count and high exacerbation...
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.
FDA Approves Dupixent for Chronic Obstructive Pulmonary Disease
WEBBy Lori Solomon HealthDay Reporter. TUESDAY, Oct. 1, 2024 -- 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 ...
Dupixent® (dupilumab) Approved in the U.S. as the First-ever …
WEBSep 27, 2024 · 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 ...
- Some results have been removed