TOKYO, December 25, 2020  - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced that its wholly owned subsidiary Audentes Therapeutics, Inc. (“Audentes” ) has been notified that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold for the ASPIRO clinical trial evaluating AT132 in patients with X-linked myotubular myopathy (XLMTM).  XLMTM is a serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death.

Astellas and Audentes are deeply committed to the continued safe development of AT132 for the families and patients living with XLMTM, a disease with no existing treatments.  Audentes is now working to complete all clinical and regulatory activities necessary to resume dosing, and plans to have discussions at a future date with the regulators on the path forward toward global registration filing for AT132.

 

Click below for a copy of the full press release