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.
HELP Therapeutics' HiCM-188 IND application receives US FDA approval
Ananda's cannabinoid medicines to feature in NHS epilepsy trials
AstraZeneca's Wainzua recommended for EU approval
Astellas Pharma's VYLOY receives US FDA approval
Accord Healthcare wins CHMP approval for Stelara biosimilar Imuldosa
Ionis and AstraZeneca's WAINZUA recommended for EU approval
Novartis receives positive CHMP opinion for Kisqali
Viatris signs exclusive licensing agreement with Lexicon Pharmaceuticals
Adicet Bio receives FDA clearance to expand ADI-001 trials to additional autoimmune diseases
GSK PLC announces acceptance of NDA for gepotidacin by US FDA
SystImmune receives FDA clearance for Phase 1 trial of novel AML therapy
Accord BioPharma's IMULDOSA receives US FDA approval to treat chronic inflammatory conditions
PTC Therapeutics' sepiapterin receives US FDA target regulatory action date
RedHill Biopharma's opaganib selected for Ebola treatment development by BARDA