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In Surprise Decision, US Approves Muscular Dystrophy Drug

WASHINGTON (AP) — U.S. health regulators approved a second drug for a debilitating form of muscular dystrophy, a surprise decision after the medication was rejected for safety concerns just four months ago.The ruling marks the second time the Food and Drug Administration has granted preliminary approval for the disease based on early results and is likely to stoke questions about its standards for clearing largely unproven medications.The FDA said late Thursday it approved Sarepta Therapeutics’ Vyondys 53 for patients with a form of Duchenne’s muscular dystrophy. Duchenne’s affects about 1 in every 3,600 boys in the U.S., causing muscle weakness, loss of movement and early death, usually when patients are in their 20s or 30s. The drug is for a specific type that affects about 8 percent of boys with Duchenne’s.In August, the FDA appeared to reject the injectable medication, sending a letter to the company that flagged risks of infections and cases of kidney injury in animal studies. But Sarepta disputed the decision, raising it to FDA’s drug center leadership. The company resubmitted its application and data, and the FDA reversed its decision, according to a Sarepta press release.The FDA said Thursday doctors should monitor the kidney function of patients taking the drug. The drug’s most common side effects include headache, fever, abdominal pain and nausea. Other reactions include rash, fever, hives and skin irritation.The surprise approval sent company shares rocketing more than 36% in trading Friday. But some Wall Street analysts said the approval suggests loosening standards at the agency.“The abruptness of the decision making at the agency does ...Read more

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