IvelinRadkov
Sanofi (NASDAQ:SNY) and its partner Regeneron (NASDAQ:REGN) announced Wednesday that the EU drug regulator, the European Medicines Agency (EMA), has approved a label expansion for their asthma therapy Dupixent to include patients with the lung disorder, chronic obstructive pulmonary disease (COPD).
The approval marks the first time a global regulatory agency has cleared the drug for COPD.
Accordingly, Dupixent, also called dupilumab, will be indicated in the EU as an add-on therapy for adults with uncontrolled COPD whose blood circulation is characterized by a high number of eosinophils, a type of white blood cells.
The approval marks the sixth approved indication for Dupixent in the region and seventh globally.
In the U.S., the FDA is expected to decide on a potential label expansion for Dupixent in COPD by September 27, 2024, after the regulator required additional data from the companies leading to a delay in its decision.