FDA Says Merck Drug Successfully Fights Hepatitis
April 26, 2011
A Food and Drug Administration review found Merck & Co.'s new hepatitis C drug cures more patients in less time than current therapies, though some safety questions remain. FDA's analysis was posted Monday ahead of a public meeting Wednesday on whether to approve boceprevir.
But FDA scientists said some late-responding patients may need to take the boceprevir combination for eight months. In addition, African Americans were among other groups who should receive longer therapy. Blacks, who comprise 20 percent of persons with HCV, had a cure rate 15 percent-25 percent lower than other racial groups. FDA also questioned boceprevir's efficacy in patients who have failed standard treatment.
Boceprevir was associated with an "increased frequency and severity of anemia," FDA said, requiring further review. And though the agency found an increased number of reported symptoms of "suicidal and homicidal ideation" with boceprevir, FDA noted "it is difficult to make any meaningful clinical conclusion from this observation."
FDA is scheduled to make a final decision on boceprevir in May. To access the agency briefing, click here.
04.25.2011; Matthew Perrone
This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the CDC's website to find out more about their activities, publications and services.
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