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| |  FDA Approves PEG-Intron/Rebetol Combination Therapy For Chronic Hepatitis C KENILWORTH, N.J. -- August 8, 2001 -- Schering-Plough Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved PEG-Intron™ (peginterferon alfa-2b) Powder for Injection for use in combination therapy with Rebetol® (ribavirin, USP) Capsules for the treatment of chronic hepatitis C in patients with compensated liver disease who have not been previously treated with interferon alpha and are at least 18 years of age. The PEG-Intron and Rebetol treatment regimen is the first and only pegylated interferon-based combination therapy approved in the United States. As previously reported, Rebetol Capsules are expected to be available nationwide sometime this fall. "PEG-Intron and Rebetol combination therapy gives new hope to some of the estimated 4 million Americans infected with the hepatitis C virus," said John G. McHutchison, MD, medical director, liver transplantation, division of gastroenterology and hepatology, Scripps Clinic and Research Foundation, La Jolla, California. "This combination therapy represents a new and effective treatment option for hepatitis C, increasing our ability to eradicate detectable levels of the virus in some patients, while providing the convenience of once-weekly dosing of PEG-Intron versus the three-times-a-week dosing of standard interferon," Dr. McHutchison said. "Over the past decade, Schering-Plough has achieved significant advances in the treatment of hepatitis C, a prevalent and serious public health problem in the United States," said Richard W. Zahn, president of Schering Laboratories. "Ten years ago, there were no approved therapies for hepatitis C. Today, with the approval of PEG-Intron and Rebetol combination therapy, physicians have an improved treatment regimen that is more convenient for patients."
WARNING Alpha interferons, including PEG-Intron, may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many but not all cases these disorders resolve after stopping PEG-Intron therapy. See WARNINGS, ADVERSE REACTIONS. Use with Ribavirin. Ribavirin may cause birth defects and/or death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with Rebetol therapy may result in a worsening of cardiac disease. Ribavirin is genotoxic and mutagenic and should be considered a potential carcinogen. (See Rebetol package insert for additional information and other warnings.) Nearly all study patients in clinical trials experienced one or more adverse events. The most common adverse events were psychiatric in nature; other common adverse events included application site inflammation and reaction, myalgia, arthralgia and nausea. In the PEG-Intron and Rebetol combination therapy trial, the incidence of serious adverse events in the PEG-Intron/Rebetol groups was similar to that in the Intron A/Rebetol group. In many but not all cases, adverse events resolved after dose reduction or discontinuation of therapy. Dose reductions due to adverse reactions occurred more frequently in the PEG-Intron/Rebetol groups than in the Intron A/Rebetol group. The most common reasons for dose modifications were neutropenia or anemia. PEG-Intron was granted marketing approval by FDA on Jan. 19, 2001, as once-weekly monotherapy for the treatment of chronic hepatitis C in patients not previously treated with interferon alpha who have compensated liver disease and are at least 18 years of age. PEG-Intron, which is approved for dosing according to patient body weight, is the first and only pegylated interferon monotherapy approved for marketing in the United States. Rebetol was granted FDA approval on July 25, 2001, as a separately marketed product for use only in combination with Intron® A (interferon alfa-2b, recombinant) Injection. Rebetol had been previously approved in the United States only as a component of REBETRON™ Combination Therapy, which contains Rebetol Capsules and Intron A in a single package. Schering-Plough continues to market Rebetron Combination Therapy in the United States. In the European Union (EU), PEG-Intron and Rebetol combination therapy was granted centralized marketing authorization by the European Commission on March 26, 2001, for the treatment of both relapsed and naive (previously untreated) adult patients with histologically proven chronic hepatitis C. PEG-Intron is a longer-acting form of Intron A that uses proprietary PEG technology developed by Enzon, Inc. of Piscataway, N.J. PEG-Intron, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly therapy designed to optimize the balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-Intron. Intron A is a recombinant version of naturally occurring alpha interferon, which has been shown to exert both antiviral and immunomodulatory effects. Schering-Plough markets Intron A, the world’s largest-selling alpha interferon, for 16 major antiviral and anticancer indications worldwide. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog. Schering-Plough has exclusive worldwide rights to market oral ribavirin for hepatitis C through a licensing agreement with ICN Pharmaceuticals, Inc. of Costa Mesa, Calif. Some 4 million Americans are infected with the hepatitis C virus (HCV) and approximately 70 percent of infected patients go on to develop chronic liver disease, according to the Centers for Disease Control and Prevention (CDC) Hepatitis C infection contributes to the deaths of an estimated 8,000 to 10,000 Americans each year and this toll is expected to triple by the year 2010, according to the CDC. The CDC has reported that HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults. It is predicted that direct U.S. medical costs to treat HCV-related disease will exceed $13 billion for the years 2010 through 2019, according to a study published in the American Journal of Public Health.
SOURCE Schering-Plough Corporation Related Link: Schering-Plough Corporation.
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