FDA Lifts Hold on Clinical Trials of Intrathecal OAV-101

FDA Lifts Hold on Clinical Trials of Intrathecal OAV-101

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FDA Lifts Hold on Clinical Trials of Intrathecal OAV-101

The U.S. Food and Drug Administration (FDA) has lifted its partial hold on clinical trials of OAV-101 (AVXS-101), an investigational intrathecal gene therapy for the treatment of spinal muscular atrophy (SMA). The agency put a hold on the open-label clinical trial STRONG in 2019, citing concerns seen in animal studies. In particular, there was concern that intrathecal administration — when a treatment is injected through the spine, directly into the fluid that surrounds the brain and…

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