FDA panel to consider new hepatitis C drug candidate from Merck
WHITEHOUSE STATION, N.J.--
Hepatitis C sufferers might have a new light going on at the end of the proverbial tunnel. Boceprevir, Merck & Co.'s experimental drug for the liver disease, cures more patients than do current therapies and works better than current drugs alone in clinical trials, says U.S. Food and Drug Administration (FDA) staff in a preliminary review. Regulators will consider whether to clear the drug, the first treatment for hepatitis C in over a decade, and external advisers to the FDA will be meeting April 27 to evaluate Merck's findings.
FDA staff noted in a preliminary report that "in general, we agreed with the applicant's analysis of the primary efficacy endpoint" of boceprevir in patients had experienced failure with prior treatments. Merck's drug candidate was also effective in treatment- naïve patients as well.
In a self-funded study of the drug, Merck found that nearly half of the patients taking boceprevir were able to shorten the duration of their treatment by 12 to 20 weeks, the company reported in a statement March 30. The study also showed that in combination with standard therapy, boceprevir cured 64 percent of chronic hepatitis-C patients for whom previous treatments had failed, compared to 21 percent of patients who took peginterferon and ribavirin without boceprevir. For the study participants who were new to treatment, 65 percent of those taking boceprevir were cured, compared with 38 percent of those strictly taking the standard therapy.
The current standard therapy combines ribavirin, an antiviral drug, with peginterferon, an immune-boosting protein sold by Merck as PegIntron and Roche Holding AG as Pegasys, which received FDA approval in 2001 and 2002 respectively. The current therapy calls for nearly a year of treatment and cures less than half of patients, according to Donald Jensen, director of the Center for Liver Diseases at the University of Chicago Medical Center.
Hepatitis C is a blood-borne disease that can lead to liver cirrhosis and cancer. According to the Centers for Disease Control and Prevention, nearly 170 million people worldwide have hepatitis C, and no vaccine exists for the disease.
Recently, though, companies like Merck have begun exploring the development of hepatitis C drugs that are more effective and demonstrate fewer side effects than the current method. Vertex Pharmaceuticals Inc. has their own drug candidate for treating hepatitis C, and FDA advisers will be meeting April 28 to review the drug, known as telaprevir. Separate trials have shown that both drugs, known as protease inhibitors, succeed in curing more patients and shortening the treatment period when combined with standard therapy. Both drugs are likely to secure FDA approval, and Geoffrey Porges, an analyst at Sanford C. Bernstein & Co. in New York, says that the drugs may hit the mark by May or June. Jensen notes that the two drugs "clearly have the ability to revolutionize the therapy for hepatitis C." Six analysts surveyed by Bloomberg estimated that sales of boceprevir might surpass $604 million in 2013.
According to the FDA staff report, side effects of boceprevir include increased frequency and severity of anemia. The agency is asking the advisory panel to carefully weigh boceprevir's benefits against the risks.