Dupixent approved in US for adults with poorly controlled COPD
WEB16 hours 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 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 ...
Sanofi, Regeneron's Dupixent Gets FDA Approval for COPD
WEB1 day ago · Dupixent was also approved for the COPD indication in China last week. Sanofi’s stock has gained 16.0% so far this year compared with an increase of 20.2% for the large cap pharmaceutical industry.
Dupixent Approved as Add-On Maintenance Therapy in COPD
WEB15 hours 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® (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. Please see Important Safety Information and Prescribing Information and …
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 ...
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 ...
FDA, after delay, clears Regeneron and Sanofi drug for COPD
WEB4 days ago · The decision makes Dupixent the first biologic medicine approved in the U.S. for COPD, a lung disease that makes it difficult to breathe and is typically treated with inhaled medicines. Regeneron estimates about 300,000 people in the U.S. have the specific type of COPD that would make them eligible for treatment with Dupixent, which is ...
Dupixent® late-breaking data from NOTUS confirmatory phase 3 COPD …
WEBMay 20, 2024 · Dupixent® (dupilumab) reduced exacerbations by 34% and improved lung function in uncontrolled COPD with type 2 inflammation, according to the NOTUS study presented at ATS and published in NEJM. Dupixent is under Priority Review by the FDA and regulatory submissions in the EU and China.
Update on FDA Priority Review of Dupixent® (dupilumab) for the ...
WEBTARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the U.S. Food …