Late on Wednesday, Sarepta Therapeutics announced that the Food and Drug Administration (FDA) has placed a clinical hold on their Phase 1/2a Duchenne Muscular Dystrophy (DMD) Micro-Dystrophin Gene Therapy Trial due to contamination of the manufacturing lot with plasmid DNA. No safety issues were reported for participants in the trial.
Sarepta has stated that they anticipate correcting the issue by manufacturing a new lot and are working with the FDA to resolve the hold. If the FDA accepts Sarepta’s action plan, the company expects there to be no delay in dosing patients as originally planned by year-end 2018.
To read Sarepta’s press release, click here.