Astellas Reports the US FDA’s Clinical Hold on the P-I/II (FORTIS) Trial of AT845 for the Treatment of Adults with Late-Onset Pompe Disease
- The US FDA has placed a clinical hold on the P-I/II (FORTIS) trial evaluating AT845 in adults with late-onset Pompe Disease. The company focuses to identify, develop & deliver therapies for patients with genetic diseases who currently have few or no viable treatment options
- The US FDA notified Astellas to needed more details regarding the recently reported SAE & thoroughly assess the risks to patients, following the occurrence of peripheral sensory neuropathy in one of the trial patients
- The company continues to collect & examine all relevant data while closely monitoring the patient's clinical course in collaboration with the site investigator & all registered patients will continue to be closely monitored
Ref: Astellas | Image: Astellas
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