Archive

Category: Avalglucosidase-alfa

Sanofi’s Avalglucosidase alfa Receives CHMP’s Positive Opinion for Patients with Pompe Disease

Shots: The CHMP’s positive opinion is based on P-III COMET study assessing avalglucosidase alfa that demonstrated improvements in respiratory function & movement endurance measures in people with late-onset Pompe disease The CHMP concluded that avalglucosidase alfa does not qualify as a New Active Substance (NAS). Sanofi will be requesting a re-examination of the CHMP’s opinion […]

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

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 […]