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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

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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

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

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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