The FDA has approved Korlym (mifepristone) 300mg tablets as a once-daily oral medicine to control hyperglycemia secondary to hypercorisolism in adults with endogenous Cushing’s syndrome, according to Corcept Therapeutics.
“We appreciate the FDA’s diligent attention to our NDA and its grant of approval on the PDUFA date,” said Joseph K. Belanoff, M.D., CEO of Corcept. “We plan to make Korlym available to patients by May 1 through a distribution system designed to support both patients and prescribers.”
Korlym 300mg blocks the glucocorticoid receptor type II (GR-II) to which cortisol normally binds. By blocking this receptor, the drug inhibits the effects of excess cortisol in Cushing’s syndrome patients. Korlym 300mg is for patients with diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery.
“Korlym is a significant advance in the treatment of patients suffering from the debilitating symptoms of Cushing’s syndrome,” said Robert L. Roe, M.D., president of Corcept. “For the first time, these patients have access to an approved therapy when surgery has failed or is not an option.”
The FDA has designated Korlym as an Orphan Drug, a special status designed to encourage the development of medicines for rare diseases and conditions, which will give Corcept marketing exclusivity until February 2019. Corcept has hired CuraScript SP, a subsidiary of Express Scripts, to dispense the drug.