Today is the day my Cushie friends and I have been waiting for. Finally, a drug therapy is available to all of us Cushies stuck in a persistent hypercortisolemic state. Korlym, the first FDA-approved drug in the United States, is available to patients who need it and want it.
I have been watching the release of this drug closely, and I found what I was looking for today. This Patient Guide for Korlym outlines all the ins and outs of taking this drug.
Today, I am happy to share the statement that was music to my ears:
"We are determined that every patient who could benefit from Korlym will receive it," added Steven Lo, Corcept's Vice President of Commercial Operations.
If you are a Cushing's patient burdened by the high costs of diagnosis -- lab work, doctor visits, travel -- please be sure to check into SPARK (Support Program for Access and Reimbursement for Korlym). I like to see them making good on that promise that the Veep made. :)
|4/10/12 - Corcept Therapeutics Announces National Product Launch of Korlym(TM) for Patients With Endogenous Cushing's Syndrome
|MENLO PARK, CA (Marketwire) 04/10/12
Corcept Therapeutics Incorporated (NASDAQ: CORT) announced today that Korlym™ (mifepristone) 300 mg Tablets is available by prescription nationwide.
On February 17, 2012, the U.S. Food and Drug Administration (FDA) approved Korlym as a once-daily oral medicine to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Korlym is the first FDA-approved treatment for this illness.
"After using mifepristone in the company's clinical trial, I am pleased that it will be available for the medical management of my patients with Cushing's syndrome for whom surgery failed," said James W. Findling, M.D., Professor of Medicine, Endocrinology at the Medical College of Wisconsin. "The majority of patients in the trial had very gratifying improvements in the clinical and metabolic manifestations of hypercortisolism."
Korlym is a once daily oral medication. The medicine's FDA-approved labeling instructs physicians to titrate each patient's Korlym dose to clinical efficacy by assessing tolerability and degree of improvement in Cushing's syndrome manifestations. In the first six weeks, these manifestations may include changes in glucose control, anti-diabetic medication requirements, insulin levels and psychiatric symptoms. After two months, assessment may also be based on improvements in cushingoid appearance, acne, hirsutism, striae or decreased body weight, along with further changes in glucose control.
"Korlym offers a new treatment strategy that has the potential to improve the lives of many patients," said Joseph K. Belanoff, M.D., the company's Chief Executive Officer. "We have worked hard to make it available as quickly as possible."
"We are determined that every patient who could benefit from Korlym will receive it," added Steven Lo, Corcept's Vice President of Commercial Operations. "Our specialty pharmacy partner, Curascript, is prepared to dispense medicine. Our Support Program for Access and Reimbursement for Korlym (SPARK) is ready with case managers to help patients navigate their medical insurance coverage and identify the Corcept and charitable foundation support programs available to them."
Physicians and patients seeking more information can visit http://www.korlymspark.com or call 1-855-4Korlym.
About Cushing's SyndromeEndogenous Cushing's syndrome is a rare and life-threatening endocrine disorder that results from long-term exposure to excess levels of the hormone cortisol. This excess is caused by tumors that usually occur in the pituitary or adrenal glands that over-produce, or prompt the over-production of, cortisol.
Although cortisol at normal levels is essential to health, in excess it causes a variety of problems, including glucose intolerance and diabetes, upper body obesity, a rounded face, stretch marks on the skin, an accumulation of fat on the back, thin and easily bruised skin, muscle weakness, bone weakness, persistent infections, high blood pressure, fatigue, irritability, anxiety, psychosis and depression. Women may have menstrual irregularities and facial hair growth, while men may have decreased fertility or erectile dysfunction. More than 70 percent of Cushing's syndrome patients suffer from glucose intolerance or diabetes.
If left untreated, Cushing's syndrome has a five-year mortality rate of 50 percent.
About Korlym™ (mifepristone) 300 mg TabletsKorlym is a once-daily oral medication that blocks the glucocorticoid receptor type II (GR-II) to which cortisol normally binds. By blocking this receptor, Korlym inhibits the effects of excess cortisol in Cushing's syndrome patients. The FDA-approved labeling instructs physicians to titrate each patient's Korlym dose to clinical efficacy by assessing tolerability and degree of improvement in Cushing's syndrome manifestations.
The FDA has designated Korlym as an Orphan Drug, a special status designed to encourage the development of medicines for rare diseases and conditions. Because Korlym is an Orphan Drug, Corcept will have marketing exclusivity for the FDA-approved indication until February 2019.
IMPORTANT SAFETY INFORMATION
WARNING: TERMINATION OF PREGNANCY
See full prescribing information for complete boxed warning.
Mifepristone has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym, or if treatment is interrupted for more than 14 days in females of reproductive potential.
To report suspected adverse reactions, contact Corcept Therapeutics at 1-855-844-3270 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the accompanying Medication Guide at www.corcept.com/medicationguide.pdf
About Corcept Therapeutics IncorporatedCorcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. Korlym, a first generation GR-II antagonist, is the company's first FDA-approved medication. The company has a portfolio of new selective GR-II antagonists that block the effects of cortisol but not progesterone. Corcept owns an extensive intellectual property portfolio covering the use of GR-II antagonists, including mifepristone, in the treatment of a wide variety of psychiatric and metabolic disorders. The company also holds composition of matter patents for its selective GR-II antagonists.
Statements made in this news release, other than statements of historical fact, are forward-looking statements. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances that clinical results will be predictive of real-world use, or regarding the pace of Korlym's acceptance by physicians and patients, the reimbursement decisions of government or private insurance payers, the effects of rapid technological change and competition, the protections afforded by Korlym's Orphan Drug Designation or by Corcept's other intellectual property rights, and the cost, pace and success of Corcept's other product development efforts. These and other risks are set forth in the Company's SEC filings, all of which are available from our website (http://www.corcept.com) or from the SEC's website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.
Investor Contact: Charles Robb Chief Financial Officer Corcept Therapeutics Incorporated 650-688-8783 Media Contact: Alyson Kuritz Communications Strategies, Inc. 973-635-6669Source: Corcept Therapeutics