FDA approves PEG-INTRON for treatment of chronic hepatitis C
PEG-INTRON is administered subcutaneously once weekly for one year. The dose should be administered on the same day of each week and may be self-administered by patients.
"Chronic hepatitis C is one of the most prevalent and serious public health problems in the United States," Richard W. Zahn, president of Schering Laboratories, stated in a company release. "PEG-INTRON offers convenient once weekly dosing that may enhance patient compliance, an important factor in determining optimal clinical outcome," Zahn said.
"While combination therapy with alpha interferon and ribavirin is a recognized standard of care for chronic hepatitis C, PEG-INTRON monotherapy offers an alternative to patients in whom combination therapy may be a contraindication or who are intolerant of this therapy," said John G. McHutchison, medical director, liver transplantation, division of gastroenterology and hepatology, Scripps Clinic and Research Foundation (La Jolla, CA).
The safety and efficacy of PEG-INTRON has been demonstrated in a randomized, controlled clinical study involving 1,219 adult patients with chronic hepatitis C who were not previously treated with alpha interferon. The study compared PEG-INTRON (0.5, 1.0 or 1.5 mcg/kg) administered subcutaneously once weekly to Schering-Plough's INTRON A (interferon alfa-2b, recombinant) Injection (3 MIU) administered subcutaneously three times weekly. Patients were treated for 48 weeks and were followed for 24 weeks post-treatment. In the study, patients receiving the 1.0 mcg/kg dose of PEG-INTRON achieved a 24% treatment response rate of sustained virologic response and ALT (alanine aminotransferase) normalization as compared to a 12% treatment response rate in patients receiving INTRON A. The safety and efficacy of PEG-INTRON in combination with ribavirin have not been established.
PEG-INTRON (peginterferon alfa-2b) is a longer-acting form of INTRON A that uses proprietary PEG technology developed by Enzon Inc. (Piscataway, NJ). PEG-INTRON, recombinant interferon alfa-2b linked to a 12,000 dalton polyethylene glycol (PEG) molecule, is a once-weekly product designed to optimize the balance between antiviral activity and elimination half-life. Schering-Plough holds an exclusive worldwide license to PEG-INTRON. The company markets the product as PEGINTRON in the European Union, where it received marketing approval in May 2000.
For more information: Schering-Plough Corp., 1 Giralda Farms, Madison, NJ 07940-1010. Tel: 973-822-7000. Fax: 973-822-7048.
Source: Schering-Plough
With contributions from Jim Pomager
Assistant Editor, Pharmaceutical Online