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 related to the NAS conclusion
• The CHMP’s positive opinion follows the EMA’s acceptance of MAA for the therapy at the end of 2020. Avalglucosidase alfa is an enzyme replacement therapy targeting M6P receptor and is currently under review in multiple countries including the US- UK & Japan

  | Ref: Sanofi | Image: Pharmaceutical Technology