Sarepta’s early-stage clinical trial for a gene therapy for Duchenne muscular dystrophy is back on schedule, the company announced Monday. The Food and Drug Administration had put the trial on hold in July.
The FDA ordered the hold after small fragments of DNA turned up in the treatment, which is being used at Nationwide Children’s Hospital in Columbus, Ohio. The contaminated lot was never used in patients, but the company said it would switch to a higher-grade of plasmids. Sarepta spokesperson Ian Estepan confirmed that the new plasmids are coming from the same supplier — something the company had floated as a possibility this summer.
About the Author Reprints
India main gene therapy Kab Tak start Hogi therapy