FDA approves Dupixent for chronic obstructive pulmonary disease
WEB1 day ago · Dupixent was associated with a 30 and 34 percent reduction in the annualized rate of moderate or severe COPD exacerbations over 52 weeks (the primary end point) versus placebo.
Dupixent approved in the US as the first-ever biologic medicine …
WEB6 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 Gets FDA Approval for COPD - WebMD
WEB1 day 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 as Add-On Maintenance Therapy in COPD
WEB2 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
WEB3 days ago · In the U.S., the expansion of Dupixent’s label to include COPD brings the number of approved indications up to six, adding to its use as a treatment for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis — all driven in part by type 2 inflammation. “Dupixent has already shown it can revolutionize the treatment paradigm ...
DUPIXENT® (dupilumab) for Adults with Inadequately Controlled COPD
WEBLearn more about DUPIXENT® (dupilumab), the first and only FDA-approved biologic treatment for adults with inadequately controlled COPD (chronic obstructive pulmonary disease) and a high number of blood eosinophils. Serious side effects can occur.
Press Release: Dupixent approved in the US as the first-ever …
WEB6 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 Approves Dupixent as First Biologic for COPD Maintenance
WEB6 days ago · On September 27, the US Food and Drug Administration (FDA) approved dupilumab (Dupixent, Sanofi/Regeneron) as an add-on maintenance treatment for adult patients with uncontrolled chronic obstructive pulmonary disease ().Dupilumab is the first biologic medicine approved in the US for COPD. The US FDA approval follows that of the European Union and China.
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
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.