The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
The BOREAS Phase III trial showed DUPIXENT reduced exacerbations by 30% and improved lung function by 160 mL at 52 weeks.
After a long road that included a three-month delay as the agency pushed for additional data, the US FDA has approved Sanofi and Regeneron's Dupixent (dupilumab) for COPD - as has China's National ...
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
Apogee Therapeutics' APG777 shows promise in treating atopic dermatitis with less frequent dosing. See why I rate APGE stock ...
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...
Dupilumab in COPD was associated with decreased risk of mortality, emergency visits, exacerbations, and respiratory failure and infections.
Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations ...
chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.