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FDA approves Korlym for Cushing's syndrome

Drug received orphan drug designation in 2007

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

The FDA announced the approval of Menlo Park, Calif.-based Corcept Therapeutics' Korlym (mifepristone) for endogenous Cushing's syndrome, a disorder that results from overproduction of cortisol, a steroid hormone that increases blood-sugar levels.

The drug is approve for patients with the disease who have Type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to surgery, and the agency said about 5,000 patients will be eligible for treatment.


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