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FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticariaThe 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.
The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...
Sanofi and Regeneron acknowledged that testing their inflammatory disease blockbuster Dupixent in chronic obstructive pulmonary disease (COPD) was likely to be high-risk when they launched phase 3 ...
Dupilumab in COPD was associated with decreased risk of mortality, emergency visits, exacerbations, and respiratory failure and infections.
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 ...
Third quarter 2024 revenues increased 11% to $3.72 billion versus third quarter 2023Third quarter 2024 Dupixent® global net sales(recorded by ...
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 ...
After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new options. This expansion positions Dupixent as the first targeted therapy for ...
After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new options. This expansion positions Dupixent as the first targeted therapy for COPD, ...
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