US-based biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) and French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Wednesday that the European Commission has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.
Dupixent is the first-ever targeted therapy for COPD. It targets adults with eosinophilia, a specific type of white blood cell, who are already on standard-of-care inhaled medications.
This approval is based on positive Phase 3 trials showing significant reductions in exacerbations, improved lung function and better health-related quality of life. Dupixent is the sixth approved use for the drug in the EU and represents a new treatment option for an estimated 220,000 patients. Regulatory submissions are ongoing in other regions.
Dupixent is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Getinge to acquire Paragonix Technologies
Bridge Biotherapeutics and HitGen sign joint research agreement
Johnson & Johnson receives FDA approval for lung cancer treatment
BerGenBio partners with Tempus to advance lung cancer drug
GSK secures Breakthrough Therapy Designation for lung cancer drug
Phanes Therapeutics' PT217 receives US FDA orphan drug designation
Akeso's ivonescimab supplemental New Drug Application receives Chinese regulator's priority review
Pfizer reports positive results for ABRYSVO RSV vaccine in immunocompromised adults