Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease

Astellas Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on January 19th for the FORTIS Ph 1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease (LOPD). Following the clinical hold lift, Astellas is working on completing the clinical and regulatory activities necessary to resume dosing in the FORTIS clinical trial.