The Food and Drug Administration has recently approved a drug for hepatitis C that offers once-weekly dosing and a drug for invasive aspergillosis.
The FDA approved Peg-Intron (peginterferon alfa-2b) powder for injection for the treatment of chronic hepatitis C in patients with compensated liver disease who were not previously treated with alpha interferon and who are at least 18 years old, according to Schering-Plough, the drug's maker. The drug is expected to become available in February.
Schering-Plough said that Peg-Intron is administered once weekly for a year and may be self-administered by the patient. The dosing schedule "may enhance patient compliance, an important factor in determining optimal clinical outcome," said Schering Laboratories president Richard W. Zahn.
Chronic hepatitis C, which often leads to the need for liver transplantation, is one of the most prevalent health problems in the United States. Peg-Intron monotherapy can be used as an alternative to the standard combination therapy of alpha interferon and ribavirin for patients who are intolerant of the combination therapy.
Schering-Plough said that it demonstrated the safety and efficacy of Peg-Intron in a randomized, controlled clinical study involving 1219 adult patients who took either once-weekly Peg-Intron or thrice-weekly Intron A (recombinant interferon alfa-2b) for 48 weeks.
"Nearly all study patients experienced one or more adverse events," the company said.
"The incidence of serious adverse events was similar (about 12%) in all treatment groups."
* The FDA has also approved Merck's Cancidas (caspofungin acetate) for the treatment of invasive aspergillosis in patients who do not respond to or cannot tolerate other antifungal therapies, amphotericin B, lipid formulations of amphotericin B, or itraconazole. Aspergillosis is a life-threatening fungal infection in high-risk patients, including the recipients of organ and bone marrow transplants. An FDA advisory committee OKd the drug in January (see "FDA Advisory Committee OKs Antifungal", Transplant News Network, January 15, 2001).
For Your Information:
See Schering-Plough's statement at www.sgp.com/news/business/2001/01-22-00.html.
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