TOKYO, January 20, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease (LOPD).

“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. “As always, we are grateful to the patients participating in the FORTIS clinical trial and we remain committed to developing novel therapies for those with a high unmet medical need.”

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.


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