FDA panel unanimously endorses Merck s boceprevir for Hepatitis C

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As most virology experts predicted (including ACSH's Dr. Josh Bloom), an FDA advisory panel voted to recommend that Victrelis (boceprivir), the first specific antiviral drug for hepatitis C, be approved by the FDA. The vote was unanimous, which is unusual. This reflects the urgent need for the drug, which has excellent efficacy, a good safety profile, and fills an unmet medical need. Developed by Schering-Plough, now part of Merck, boceprevir is an oral drug that would be taken along with the current standard of care, the interferon-plus-ribavirin regimen. Rapid FDA approval is anticipated.

One study found that 66 percent of patients receiving boceprevir with pegylated interferon and ribavirin were able to clear the virus, compared with 38 percent of those who received only interferon and ribavirin. Other studies have shown that boceprevir can shorten the length of treatment, which is often terminated early because of serious adverse side-effects from interferon. Hepatitis C is a viral disease that almost always remains asymptomatic for decades and causes chronic liver disease. It is estimated that the worldwide burden of hepatitis C — a known precursor of liver cancer — is about 3 percent.

Dr. Bloom notes that “this is a culmination of 22 years of remarkable work. Before 1989, no one even knew about the hepatitis C virus (HCV). Once this was solved, virtually every major drug company had an HCV program. The techniques first developed for the AIDS drugs were applied to HCV research. Although this breakthrough took considerably longer than for AIDS (several drugs failed in the clinic), scientists persisted, and today, we are seeing the results of these efforts. When the FDA approves the drug, it will be a historic day in pharmaceutical research.”