Sanofi's Pompe Disease Enzyme Replacement Therapy Gets EMA's CHMP Backing - Sanofi (NASDAQ:SNY)

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sanofi SA's SNY avalglucosidase alfa for Pompe disease.
The positive opinion is based on Phase 3 COMET study data, which showed avalglucosidase alfa improved respiratory function and movement endurance measures.
Avalglucosidase alfa is a long-term enzyme replacement therapy designed to target the mannose-6-phosphate (M6P) receptor, the underlying disease mechanism in Pompe disease.
The CHMP positive opinion for avalglucosidase alfa follows the EMA's acceptance of Sanofi's application at the end of 2020.
Avalglucosidase alfa is also currently undergoing review in the U.S., U.K., and Japan. The FDA action date is August 18.
Price Action: SNY shares are down 0.23% at $51.51 during the market session on the last check Tuesday.
Related content: Benzinga's Full FDA Calendar.