FDA Puts Clinical Hold on Astellas Late-Onset Pompe Disease Clinical Trial
The FDA has placed a clinical hold on Astellas’ phase 1/2 study of AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adult patients with late-onset Pompe disease.
The clinical hold followed a serious adverse event in the trial in which one participant experienced peripheral sensory neuropathy.
The FDA said it placed the hold on the trial because it needs to see more information in order to assess the therapy’s risks.
Astellas said the site investigator has classified the serious adverse event as “mild in severity.”