“On June 26, 2022, Astellas Pharma, Inc. (“Astellas”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on the FORTIS Phase 1/2 clinical trial evaluating AT845 (“the investigational gene therapy candidate”) in patients with Late Onset Pompe Disease (LOPD). The hold was placed following the occurrence of a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants.” – Weston Miller, MD (Senior Medical Director, Clinical Development) and Hilary D’Anna (Senior Manager, Patient Advocacy & Engagement)
Click here to read the press release.