Blockbuster Dupixent wins FDA approval for COPD - STAT
WEB3 days ago · Sept. 27, 2024. West Coast Biotech & Life Sciences Reporter. Dupixent is already a blockbuster therapy for a range of immune-mediated diseases, but the Food and Drug Administration’s approval of ...
Sanofi and Regeneron Biologic Drug Dupixent Notches a New FDA …
WEB1 day ago · By Frank Vinluan on September 29, 2024. The blockbuster Sanofi and Regeneron Pharmaceuticals drug Dupixent, already commercialized in several skin and lung disorders, has expanded its FDA-approval ...
Dupixent approved in the US as the first-ever biologic medicine …
WEB3 days ago · Paris and Tarrytown, NY, September 27, 2024. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US to treat these ...
FDA signs off on Regeneron and Sanofi's Dupixent for COPD
WEB3 days ago · They based their figure on 30% uptake of the treatment for those who are eligible. The addition would put Dupixent’s sales potential at $20 billion by the end of this decade, making it one of ...
FDA greenlights Regeneron’s Dupixent for the treatment of COPD
WEB2 days ago · Treatment with Dupixent was shown to reduce COPD exacerbations by 30% in the BOREAS trial and by 34% in the NOTUS trial over 52 weeks. Additionally, the biologic was associated with improvements ...
Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'
WEB3 days ago · The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the companies said ...
Dupixent® (dupilumab) Approved in the U.S. as the First-ever
WEB3 days ago · “This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the U.S. who can sometimes struggle just to breathe during their everyday lives ...
DUPIXENT® (dupilumab) for Adults with Inadequately Controlled …
WEBA Breakthrough Treatment FOR COPD is Here. DUPIXENT is an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). Not actual patients. SHARE THE NEWS: DUPIXENT IS APPROVED FOR COPD!
FDA Approves Dupilumab (Dupixent) for Treatment of COPD
WEB3 days ago · Regeneron has announced the US Food and Drug Administration (FDA) approval of dupilumab (Dupixent) for individuals with chronic obstructive pulmonary disease (COPD). 1. Announced on September 27, 2024, the FDA’s decision, which is based on data from the BOREAS and NOTUS trials, comes less than 4 months after the organization extended the original target action date for Regeneron and Sanofi ...
FDA, after delay, clears Regeneron and Sanofi drug for COPD
WEB3 days ago · European regulators approved Dupixent for COPD in July, but Regeneron and Sanofi have had to wait longer in the U.S., where the FDA requested additional efficacy data from the two trials. Over that time, a potential new competitor has emerged in GSK’s Nucala, which the FDA rejected in 2018 but earlier this month succeeded in a Phase 3 trial.