Sanofi’s pompe disease therapy adopted for positive opinion by the European Medicines Agency

FRANCE – The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sanofi’s avalglucosidase alfa,a long-term enzyme replacement therapy for the treatment of people with Pompe disease. CHMP’s positive opinion and recommended indication reflect the robust data from avalglucosidase alfa’s clinical development program. The positive opinion is based on data from the Phase 3 COMET study, which found that avalglucosidase alfa showed clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease. Avalglucosidase alfa is…

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