By Chris Wack

 

Novartis AG said the U.S. Food and Drug Administration has determined that OAV-101 intrathecal clinical trials for spinal muscular atrophy patients can proceed, lifting the partial clinical trial hold initiated in October 2019.

The company said the decision to lift the hold was based on data from its nonclinical toxicology study in non-human primates that addressed all issues identified, including questions of dorsal root ganglia injury following IT administration.

Following the decision and input from the FDA and European Medicines Agency, Novartis plans to initiate a global Phase 3 registration-enabling study to evaluate the clinical efficacy, safety, and tolerability of OAV-101 IT in treatment naive patients who are between two and 18 years of age, able to sit, but have never walked.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 03, 2021 06:45 ET (10:45 GMT)

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