Corcept Therapeutics Incorporated, a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, announced that the US Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA), which was submitted on April 15, 2011, for Corlux, a glucocorticoid receptor type II (GR-II) antagonist, for the treatment of the manifestations of cushing’s syndrome.
The FDA has indicated that this application will receive a standard review and that the Prescription Drug User Fee Act (PDUFA) goal date for completion of its review is February 17, 2012.
We are executing our commercial plans related to Corlux for the treatment of cushing’s syndrome based on the projected timeline for the FDA review of our NDA. This includes conducting market research and engaging third-party vendors to support distribution and other logistical needs for product launch, if Corlux is approved by the FDA.
“Many patients with cushing’s syndrome suffer debilitating manifestations of their disease, despite receiving the best available treatment,” said Joseph K Belanoff, MD, chief executive officer at Corcept. “In our phase III study, Corlux demonstrated its potential to significantly improve the clinical condition of these patients in a wide variety of important ways. We believe that Corlux has the potential to provide a meaningful advance over the current standard of care for patients with cushing’s syndrome and are gratified to receive the formal notice of the FDA’s acceptance of the NDA for filing.”
Endogenous cushing's syndrome results from prolonged exposure of the body's tissues to high levels of the hormone cortisol generated by tumours. Cushing’s syndrome is an orphan indication which most commonly affects adults aged 20 to 50. Symptoms vary, but most patients have one or more of the following: diabetes mellitus, high blood pressure, weight gain, a rounded face, increased fat around the neck, severe fatigue, weak muscles, osteoporosis, skin changes, infections, poor quality of life irritability, anxiety and depression.
Corcept’s first-generation compound, Corlux, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone (PR) receptor. Intellectual property protection is in place to protect important methods of use for Corlux.