BRIEF—FDA lifts clinical hold on Astellas AT845 trial

The US Food and Drug Administration (FDA) has lifted the clinical hold on the FORTIS Phase I/II clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease (LOPD), Japanese drug major Astellas Pharma announced today.

“With that same spirit and focus on patient safety, we look forward to resuming the FORTIS clinical trial and the continued development of AT845 as an important potential new treatment for adults living with LOPD,” said Ha Tran, executive medical director for Astellas.

Following the clinical hold lift, Astellas is working on completing the clinical and regulatory activities necessary to resume dosing in the FORTIS clinical trial.

The clinical hold lift will have no impact on Astellas’ financial forecasts of the current fiscal year ending March 31, 2023, the company noted.