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
