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The FDA has placed a clinical hold on Astellas Pharma Inc's (OTC: ALPMY) FORTIS Phase 1/2 trial following a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants.
FORTIS trial is evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease.
The FDA has informed Astellas that it did not have sufficient information to assess the risks to subjects and requires additional information about the recently reported SAE.
To date, the site investigator has classified the SAE as Grade 1 (mild in severity) and deemed serious due to medical significance.
Astellas is working closely with the site investigator to follow the patient's clinical course and will continue gathering and reviewing all relevant data.
All enrolled participants will continue to be monitored closely per the study protocol.
Astellas is reviewing the potential financial impacts of this matter for the fiscal year ending March 31, 2023.
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