Corcept Therapeutics Inc. said Thursday that regulators accepted its application to market the drug Corlux as a treatment for the rare disease Cushing's Syndrome.
Corcept said the Food and Drug Administration expects to decide whether to approve Corlux by Feb. 17. The company filed for approval on April 15, and FDA reviews usually take about 10 months.
Cushing's Syndrome is caused when tumors cause a person's body to produce too much of the hormone cortisol. Its symptoms can include high blood sugar, high blood pressure, fatigue and muscle weakness. Corcept said about 20,000 people in the U.S. have the condition.
Earlier this month, Corcept reported results from late-stage testing that showed Corlux improved patients' blood sugar levels and blood pressure, and decreased body weight and waist circumference.
If the drug is approved, Corcept will have seven years of marketing exclusivity because the FDA awarded Corlux orphan drug status, an incentive given to treatments for rare diseases. The company is also studying Corlux as a treatment for psychotic depression.
Corcept shares fell 13 cents, or 3.1 percent, to $4.12 in premarket trading. The stock has traded between $2.76 and $5.07 in the last year.