WHITEHOUSE STATION, N.J.— The Antiviral Drugs AdvisoryCommittee of the U.S. Food and Drug Administration (FDA) has voted unanimously18-0 that the available data provided by Merck (known as MSD outside the UnitedStates and Canada) for its investigational medicine VICTRELIS (boceprevir)support approval of the medicine. VICTRELIS is meant for the treatment ofchronic hepatitis C virus (HCV) genotype 1 infection in combination with currentstandard therapy.
"We're pleased with the panel's decision and look forward toworking with the FDA as it continues to evaluate the application forVICTRELIS," says Peter Kim, Ph.D., president of Merck Research Laboratories.
The FDA will consider the committee's recommendation whenits reviews the New Drug Application for VICTRELIS. The FDA has grantedVICTRELIS with priority review status, which is reserved for investigationaldrugs that address significant unmet medical needs. Merck is anticipating FDAaction on the drug by mid-May. Similarly, the Marketing AuthorizationApplication for VICTRELIS has been accepted for accelerated assessment by theEuropean Medicines Agency.
VICTRELIS is an HCV protease inhibitor, a new class ofmedicines that is being evaluated for treating hepatitis C in patients who havenot undergone treatment previously or who have failed previous therapy.
The data reviewed by the panel came from the Phase IIIclinical study program for the drug, and the clinical trials HCV SPRINT-2 andHCV RESPOND-2 included about 1,500 patients with chronic HCV genotype 1, whichis the most common form of hepatitis in the U.S. and most difficult form totreat. The results from the two trials were published in the March 31 issue ofthe New England Journal of Medicine.
"The positive recommendation brings us one step closer tobringing VICTRELIS to men and women who need it, and reinforces our ongoingcommitment to developing innovative therapies to treat chronic hepatitis C,"says Kim.
The need for new treatment is obvious, as about 170 millionpeople worldwide, 3.2 million of those in the U.S., suffer from chronichepatitis C, and no vaccine exists for the virus. Additionally, Merck reportedin a briefing document for the FDA that the current standard therapy thattreats the most common strain of hepatitis C consists of 48 weeks of treatmentand cures less than half of patients.
Merck's study discovered that when combined with standardtherapy, VICTRELIS cured 63 percent of patients with hepatitis C who had failedprevious treatments, as opposed the 23 percent that were cured with thestandard therapy alone. Additionally, of those patients who were new totreatment, 65 percent of who dosed with VICTRELIS were cured, compared to the38 percent of those treated with the standard therapy.
Given that those who were previously treated for hepatitis Cand failed to respond to VICTRELIS weren't included in Merck's trials,panelists recommended that the FDA require a caution in the drug's label,notifying users that it hasn't been studied in "null responders." Panel membersalso recommended that post-marketing studies of those patients, as well aspeople with HIV, organ transplant recipients and those taking durgs such asantidepressants, should be required.
"Itchanges the game completely and hopefully continues to advance the field," saysVictoria Cargill, the acting chairwoman of the Antiviral Drugs AdvisoryCommittee and director of minority research at the National Institutes ofHealth Office of AIDS Research in Bethesda, Md.
