ALPMY - Astellas gene replacement therapy trial put on hold by FDA after nerve issue in patient

Astellas Pharma (OTCPK:ALPMY) (OTCPK:ALPMF) said the U.S. Food and Drug Administration (FDA) placed a clinical hold on a trial of its gene replacement therapy AT845 after a serious adverse event (SAE) of damage to peripheral nerves in one patient was reported. The phase 1/2 trial, dubbed FORTIS, evaluating AT845, an investigational adeno-associated virus (AAV) gene replacement therapy in adults with Late-Onset Pompe Disease — a rare genetic disorder is characterized by  skeletal muscle weakness affecting mobility and the respiratory system. The company said in a June 26 press release that a SAE of peripheral sensory neuropathy in one patient was reported. Peripheral neuropathy is a damage to the nerves outside the brain and spinal cord (peripheral nerves), causing weakness, numbness and pain, usually in the hands and feet. The Japanese drugmaker said to date, the SAE has been classified by the site investigator as grade 1 (mild in severity) and deemed serious due to medical

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Astellas gene replacement therapy trial put on hold by FDA after nerve issue in patient