FDA Expert Panel to Review Merck's New HIV Treatment Isentress in September
July 12, 2007
On Sept. 5, the Food and Drug Administration's antiviral panel will meet to assess the safety and efficacy of Isentress, a new HIV drug from Merck & Co. The drug's target market is patients who no longer respond to at least one drug in three antiviral classes. FDA last month granted priority review status to Isentress, a designation that acknowledges the candidate drug fills an urgent medical need and that reduces, from 10 months to six, the length of the review period. Merck said its trials show Isentress effectively reduced HIV viral load in more than 75 percent of study patients. FDA typically follows the advice of its expert panels; a final decision is anticipated by mid-October.
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.