Dupixent approved in the US as the first-ever biologic medicine …
WEB3 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 ...
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 ...
FDA signs off on Regeneron and Sanofi's Dupixent for COPD
WEB3 days ago · The companies began testing Dupixent in COPD in 2018, taking a risk by going straight to phase 3. When interim results for the BOREAS trial were positive, Sanofi kicked off a second phase 3 trial ...
DUPIXENT® (dupilumab) for Adults with Inadequately Controlled COPD
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!
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
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.
Dupilumab Becomes First Biologic Approved in the US as Targeted …
WEB3 days ago · September 27, 2024. By Grace Halsey. News. Article. Dupilumab represents the first new treatment approach for uncontrolled COPD in more than a decade and reduced disease exacerbations by 34% in clinical trials. Sanofi and Regeneron Pharmaceuticals announced today that the US FDA has approved the biologic dupilumab (Dupixent) as …
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 ...
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 ...