FDA approves Corcept's hormonal disorder drug

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Fri Feb 17, 2012 9:33pm GMT

(Reuters) - U.S. regulators approved Corcept Therapeutics's drug to treat a rare hormonal disorder called Cushing's syndrome.

The U.S. Food and Drug Administration approved the drug, to be sold under the name Korlym, for a condition in which the body produces unusually high levels of a steroid hormone called cortisol, potentially leading to diabetes, high blood pressure and upper body obesity.

However, Korlym's label will carry a boxed warning advising doctors and patients that the therapy will terminate a pregnancy.

The condition affects about 20,000 people in the United States, mainly aged 20 to 50, and can be fatal if untreated, the company said.

(Reporting by Anna Yukhananov in Washington and Anand Basu in Bangalore)

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