FDA investigating risk of acute liver failure with Sarepta’s Elevidys

Since approval of Sarepta’s (SRPT) Elevidys, the Food and Drug Administration has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male patients with Duchenne muscular dystrophy, the agency said in a statement. “FDA is investigating the risk of acute liver failure with serious outcomes, including those such as hospitalization and death, following Elevidys, and is evaluating the need for further regulatory action,” the agency said in a statement.