The FDA has approved Corcept Therapeutics Korlym (mifepristone) 300mg tablets as a once-daily oral medicine to treat Cushing's syndrome patients.
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Korlym controls hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery.
Corcept CEO Joseph Belanoff said they plan to make Korlym available to patients by May 1 through a distribution system designed to support both patients and prescribers.
"We appreciate the FDA’s diligent attention to our NDA and its grant of approval on the PDUFA date," Belanoff added.
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