FDA Extends Review of Avalglucosidase Alfa, Next-gen ERT, Into August

FDA Extends Review of Avalglucosidase Alfa, Next-gen ERT, Into August

293544

FDA Extends Review of Avalglucosidase Alfa, Next-gen ERT, Into August

The U.S. Food and Drug Administration (FDA) has extended by three months its review of Sanofi Genzyme‘s application seeking approval of avalglucosidase alfa, its next-generation enzyme replacement therapy (ERT) for Pompe disease. The date for an agency decision regarding approval, previously set for May 18, is now Aug. 18. “Sanofi remains deeply committed to delivering on our promise to raise the standard of care for people living with Pompe disease and will continue to work closely with the FDA,”…

You must be logged in to read/download the full post.