Corcept Therapeutics Inc. (CORT) won U.S. approval for a drug that uses the active ingredient of the abortion pill RU-486 to treat Cushing’s Syndrome.
The Food and Drug Administration cleared Korlym, formerly called Corlux, to treat the syndrome in patients who have Type 2 diabetes or glucose intolerance and aren’t candidates for surgery or haven’t responded to surgery, the agency said today in a statement. Korlym, the leading drug candidate from Menlo Park, California-based Corcept, is the first therapy approved for the hormone condition, the FDA said.
Korlym, a once-daily pill, will be available on May 1 through a small number of endocrinologists who treat patients affected with the disease, Joseph Belanoff, Corcept’s chief executive officer, said today in a statement.
“These doctors can be reached without a large sales and marketing infrastructure,” he said.
Cushing’s Syndrome affects about 20,000 people in the U.S., Corcept said in a statement. The illness, caused by too much exposure to the hormone cortisol, most often attacks adults 20 to 50 years old, according to the U.S. National Institutes of Health. Symptoms include high-blood pressure, upper-body obesity and diabetes. The disease can be lethal if not treated effectively.
Korlym blocks cortisol with mifepristone, which is approved for the termination of early pregnancy in combination with the drug misoprostol. The drug will carry a boxed warning that it will terminate a pregnancy.
Corcept’s medicine was granted orphan drug status because it treats a small number of patients, which means it is eligible to be sold free from generic competition for seven additional years. About 5,000 patients will be eligible for the drug, the FDA said in its statement.
Corcept shares gained 64 percent to $4.97 in extended trading at 6:55 p.m. New York time. The company, which hasn’t generated revenue since 2009, declined 27 percent in the past 12 months.
Physicians may not readily accept Korlym as a treatment for Cushing’s, Corcept said Sept. 30 in its quarterly report because doctors are inexperienced with the condition and because of the ethical and political implications of the abortion drug.
“Public perception of the active ingredient in Korlym, mifepristone or RU-486, may limit our ability to market and sell Korlym,” the company said.
Corcept said it will control the distribution of the drug to reduce the potential for ending a pregnancy. The company also is studying alternative uses for the treatment.
Korlym failed in 2007 in a clinical trial for psychotic major depression. The FDA granted the drug fast-track status, which garners Corcept more meetings with agency staff to facilitate development of the medicine. No FDA-approved treatment exists for psychotic depression, according to Corcept.
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