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| |  Europe Approves Pegintron (Peginterferon Alfa-2b), Rebetol (Ribavirin) Combo Therapy For Hepatitis C KENILWORTH, NJ -- March 28, 2001 -- Schering-Plough Corporation announced that the European Commission of the European Union (EU) has granted centralized marketing authorization to Pegintron™ (peginterferon alfa-2b) Injection and Rebetol® (ribavirin) Capsules as combination therapy for the treatment of both relapsed and naive (previously untreated) adult patients with histologically proven chronic hepatitis C. Commission approval of Pegintron and Rebetol results in unified labeling that is immediately valid in all 15 EU-Member States and Iceland and Norway. The Commission's decision follows recommendation for approval in December 2000 by the EUFs Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA). The pivotal clinical study on which the marketing authorization is based demonstrated that Pegintron and Rebetol combination therapy was significantly more effective (61 percent vs. 47 percent) in achieving a sustained virologic response (SVR) in patients receiving the recommended combination regimen than the combination of interferon alfa-2b (Intron® A) and Rebetol, particularly in patients infected with Genotype 1 virus (48 percent vs. 33 percent). SVR is defined as sustained loss of detectable(1) hepatitis C virus (HCV-RNA(2)) at six months after the cessation of treatment. The study showed that SVR rates were increased if patients were able to maintain compliance. Regardless of genotype, patients who received the recommended combination regimen and received >80 percent of their treatment with Pegintron and Rebetol had a higher SVR than those who took <80 percent of their treatment (72 percent vs. 46 percent). "The approval of Pegintron and Rebetol combination therapy in Europe represents a significant advance in the treatment of chronic hepatitis C, one of the most prevalent public health problems we face today," said Thomas C. Lauda, executive vice president, Schering-Plough Pharmaceuticals. "We have learned that, in addition to genotype, body weight is an important factor in optimizing clinical outcome. The dosing flexibility provided by Pegintron and Rebetol allows physicians to tailor treatment doses to an individual patient's needs," Lauda said. The authorization recommends Pegintron be administered as a once-weekly subcutaneous injection at a dose of 1.5 mcg/kg when used in combination with Rebetol capsules. The dose of Rebetol to be used in combination with Pegintron is based on patient body weight (<65kg/800 mg/daily; 65-85 kg/1,000 mg/daily; >85 kg/1,200 mg/daily). Ribavirin capsules are to be administered orally each day in two divided doses with food (morning and evening). It is recommended that patients be treated initially with the combination therapy for six months. In patients showing loss of HCV-RNA at six months, treatment is to be continued for an additional six months, i.e., one year of treatment. In a pivotal Phase III, randomized, controlled clinical study of two dosing regimens of Pegintron in combination with Rebetol compared to interferon alfa-2b (INTRON A) in combination with Rebetol, a total of 1,530 previously untreated patients from 62 sites worldwide (33 U.S., 5 Canada, 22 Europe, 2 other) were treated in one of three treatment arms: (A) Pegintron Injection 1.5 mcg/kg once weekly (QW) plus Rebetol Capsules 800 mg/daily for 48 weeks (PEG 1.5/R); In this study, SVR rates were shown to be dependent on the dose of Rebetol administered in combination with Pegintron or interferon alfa-2b (INTRON A). In those patients who received >10.6 mg/kg/daily Rebetol (800 mg dose in typical 75 kg patient), regardless of genotype or viral load, SVR rates were significantly higher than in those patients who received <10.6 mg/kg/daily Rebetol. In clinical studies, the combination of Pegintron and Rebetol had a comparable safety profile as the combination of interferon alfa-2b and Rebetol. The most frequently reported adverse events with Pegintron and Rebetol combination therapy (fatigue, fever, headache and rigors) were also the most frequently reported adverse events with interferon alfa-2b and Rebetol combination therapy. Pegintron had previously received centralized marketing authorization in the EU and is marketed as monotherapy in cases of intolerance or contraindication to ribavirin for the treatment of adult patients with histologically proven chronic hepatitis C. Pegintron (peginterferon alfa-2b) is a longer-acting form of Intron A that uses proprietary PEG technology developed by Enzon, Inc. of Piscataway, N.J. Pegintron, 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 Pegintron. Rebetol had previously received centralized marketing authorization in the EU and is marketed for use in combination with Schering-Plough's interferon alfa-2b injection (marketed as Introna™ in EU countries) for the treatment of both relapsed and naive adult patients with chronic hepatitis C. Rebetol is an oral formulation of ribavirin, a synthetic nucleoside analog with broad-spectrum antiviral activity. Schering-Plough has exclusive rights to market oral ribavirin for hepatitis C in all major world markets through a licensing agreement with ICN Pharmaceuticals, Inc. of Costa Mesa, California. Chronic hepatitis C is estimated to affect some 10 million people in major world markets. As many as 5 million Europeans (1 to 2 percent of the general population) are chronically infected with the hepatitis C virus, according to a study conducted by the World Health Organization (WHO). In Europe, chronic hepatitis C is the leading cause of chronic liver disease and the most common reason for liver transplant. (1)Defined as HCV-RNA below limit of detection using a research-based RT-PCR assay.
SOURCE Schering-Plough Corporation Web Site: http://www.schering-plough.com.
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