Korlym Approved for Cushing's Syndrome
MONDAY, Feb. 20 -- Korlym (mifepristone) has been approved by the U.S. Food and Drug Administration to treat endogenous Cushing's syndrome, a disabling disorder caused by overproduction of the so-called "stress hormone," cortisol.
Cortisol is produced by the adrenal glands and increases blood sugar, making it particularly dangerous for people with diabetes. Korlym does not decrease production of the hormone, but reduces the effects of overproduction, the FDA said in a news release.
The approval is for people with endogenous (of internal cause) Cushing's syndrome who have type 2 diabetes and who either haven't responded to previous surgery or aren't candidates for new surgery. Only about 5,000 people in the United States are likely to be eligible for the drug, the agency said.
The medication was evaluated in clinical studies involving 50 people. Participants who took Korlym had "significant improvement in blood sugar control," the FDA said.
Although the chances of a person with Cushing's syndrome becoming pregnant are slim, Korlym 's label warns that the drug should never be used by expectant women, since it is likely to "terminate a pregnancy," the agency said.
Common side effects observed during clinical testing included nausea and vomiting, fatigue, headache, swelling of the extremities, dizziness and loss of appetite.
Korlym is produced by Corcept Therapeutics, based in Menlo Park, Calif.
To learn more about Cushing's, visit Medline Plus.
Posted: February 2012