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Sanofi's Pompe Disease Enzyme Replacement Therapy Gets EMA's CHMP Backing

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  • The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sanofi SA's (NASDAQ: 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.

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