Sarepta Therapeutics, Inc. (NASDAQ:SRPT) stock jumped on Friday after the FDA issued a new boxed warning for Elevidys. The updated approval follows recent reports of fatal liver injury in non-ambulatory pediatric patients who received the gene therapy.
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The FDA has updated the labeling for Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), by adding its highest-level safety warning--a Boxed Warning--and restricting its approved use.
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Elevidys can now only be given to ambulatory patients aged four or older with a confirmed DMD gene mutation due to reports of fatal acute liver failure in non-ambulatory patients who received the therapy, according to the FDA.
Following these fatalities, Sarepta voluntarily halted use for non-ambulatory patients.
In the reported fatal cases, affected children showed severely increased liver enzymes and needed hospitalization within two months of getting the treatment.
Another non-fatal but serious liver injury case included complications like mesenteric vein thrombosis, bowel damage, tissue death, and portal hypertension.
After reviewing all available safety information, the FDA approved several important label changes:
- Added a prominent Boxed Warning about the risk of severe and possibly fatal liver damage.
- Restricted eligibility to walking (ambulatory) patients aged four and older, excluding non-ambulatory patients.
- Introduced new guidance on when the therapy should and shouldn't be used, with updates throughout the safety, dosing, side effect, and patient counseling sections.
- Released a new Medication Guide for patients and caregivers.
SRPT Price Action: Sarepta shares have fallen nearly 50% over the past six months, according to data from Benzinga Pro. The stock jumped on the FDA news Friday, closing 5.56% higher at $18.81.
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