press release
June 5, 2012, 8:02 a.m. EDT
Kadmon Launches 600 mg/day Ribasphere(R) RibaPak(R) to Provide Added Dosing Control for Triple Therapy Treatment of Chronic Hepatitis C
NEW YORK, NY, Jun 05, 2012 (MARKETWIRE via COMTEX) -- Kadmon Pharmaceuticals, LLC, the commercial division of Kadmon Corporation, LLC, today announced that it has launched a new 600 mg/day dose pack of Ribasphere(R) RibaPak(R) (ribavirin, USP), Kadmon's proprietary ribavirin regimen, and the only ribavirin available in a daily, two-pill compliance package for enhanced therapy adherence. The new dose pack is designed to provide added dosing control to improve the management of hemolytic anemia in certain patients prescribed the triple therapy of a protease inhibitor, pegylated alpha interferon and ribavirin for the treatment of chronic hepatitis C virus infection.
"Anemia, particularly severe anemia, is an important concern with hepatitis C treatments, one which may be effectively controlled through ribavirin dose reduction," said John Ryan, Ph.D., M.D., Executive Vice President and Chief Medical Officer of Kadmon. "Anemia can also affect treatment adherence and a patient's ability to complete therapy. The new 600 mg/day Ribasphere(R) RibaPak(R) dose pack ensures that physicians can seamlessly reduce ribavirin dose without compromising the adherence advantages of RibaPak(R)."
Pooled data from studies of the protease inhibitors VICTRELIS(R) (boceprevir) and INCIVEK(TM) (telaprevir), approved in 2011 for the treatment of genotype 1 chronic hepatitis C virus, show that anemia was a frequently observed adverse event in both treatment-naive and treatment-experienced patients (Pearlman BL, et al. Journal Options Hepatitis. 2011;5:1), in some cases exhibiting a doubling of incidence over control (peginterferon/ribavirin). In clinical studies, anemia has been managed with ribavirin dose reduction and/or with off-label use of erythropoietin (Pearlman BL, et al. Journal Options Hepatitis. 2011; 5:1).
With the new 600 mg/day dose pack, Ribasphere(R) RibaPak(R) is now available in four dosing options: 600 mg/day, 800 mg/day, 1000 mg/day, and 1200 mg/day. Ribasphere(R) RibaPak(R) offers a unique packaging and dosage form designed to simplify treatment, reducing ribavirin pill burden by up to 66% over a 48 week course of treatment, and to make it easier for the patient to keep track of their treatment. Adherence to therapy is an important component in the successful treatment of hepatitis C. The risk of non-compliance includes treatment failure or relapse (Reddy KR, Shiffman ML, Morgan TR, et al. Clin Gastroenterol Hepatol. 2007;5:124-129) and, because of the direct antiviral mechanism of protease inhibitors, missed doses of a protease inhibitor could lead to viral resistance (Weiss, et al. Aliment Pharmacol Ther 2009; 30:14-27).
About Hepatitis C
Hepatitis C is a liver disease that results from infection with the hepatitis C virus ("HCV"). Hepatitis C virus can either be "acute" or "chronic." Acute hepatitis C virus infection is a short-term illness that occurs within the first six months after someone is exposed to the hepatitis C virus. Seventy five-85% of acute HCV infections become chronic HCV infections. Chronic hepatitis C virus is a serious disease than can result in long-term health problems, such as serious liver disease, including cirrhosis and liver cancer, or even death. An estimated 4 million Americans are infected with the hepatitis C virus.
About Ribasphere(R) RibaPak(R) (ribavirin, USP)
INDICATION
Ribasphere(R) (ribavirin, USP) in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha.
IMPORTANT SAFETY INFORMATION
Ribasphere(R) (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (see WARNINGS). The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin. Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6 month post treatment follow-up period.
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