Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease

November 18, 2020 Auto Bot BLA, Pompe disease, Priority Review, receives, regulatory, Sanofi, Us FDA 0

Shots:

  • The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date for the FDA decision is May 18, 2021
  • The BLA is based on positive data from two trials: P-III COMET study and P-II mini-COMET study and the results from both the studies were presented at World Muscle Society and the American Association of Neuromuscular & Electrodiagnostic Medicine and WORLDSymposium respectively
  • Avalglucosidase alfa is an investigational enzyme replacement therapy designed to improve the delivery of GAA enzyme to muscle cells, and it would become a potential new SoC for patients with Pompe disease (if approved)

Click here ­to­ read full press release/ article | Ref: Sanofi | Image: Sanofi

The post Sanofi’s Avalglucosidase alfa Receives US FDA’s Priority Review as Enzyme Replacement Therapy for Pompe Disease first appeared on PharmaShots.