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Sanofi: FDA Grants Priority Review For Avalglucosidase Alfa - Quick Facts

Sanofi (SNYNF,SNY) said the FDA has accepted for priority review the Biologics License Application for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date is May 18, 2021. The company's BLA is based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, respectively.

Sanofi noted that, in October, the European Medicines Agency accepted for review the Marketing Authorization Application for avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease.

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