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Europe Accepts Sanofi's Regulatory Submission For Enzyme Replacement Therapy For Pompe Disease

Sanofi (SNYNF,SNY) said that the European Medicines Agency or EMA has accepted to review the Marketing Authorization Application of avalglucosidase alfa, an investigational enzyme replacement therapy for the treatment of patients with Pompe disease.

The company expects to receive regulatory approval for the therapy in Europe in the second half of 2021.

Pompe disease is a rare, degenerative muscle disorder that can impact an individual's ability to move and breathe. It affects an estimated 50,000 people worldwide and can manifest at any age from infancy to late adulthood.

Avalglucosidase alfa has received Promising Innovative Medicine designation in UK, and also received U.S. Breakthrough Therapy designation earlier this year.

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