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Story summary
- The U.S. Food and Drug Administration restricted Elevidys to ambulatory Duchenne muscular dystrophy (DMD) patients four years and older after two deaths from liver failure.
- The updated label adds a boxed warning for liver injury and failure.
- Elevidys is contraindicated for patients with preexisting liver conditions or recent infections.
- Sarepta Therapeutics plans a study on an immunosuppressive regimen to mitigate risks.
- The decision follows a turbulent period and DMD advocacy.
