FDA Panel To Review Merck’s Antiretroviral Raltegravir in September
An FDA panel of experts will review Merck's experimental antiretroviral drug raltegravir in September, the agency announced on Wednesday, the AP/Yahoo! Finance News reports (AP/ Yahoo! Finance News, 7/11). Merck in June announced that FDA granted priority review status to raltegravir, an experimental integrase inhibitor. Raltegravir effectively decreases HIV viral loads after 24 weeks of use among HIV-positive people who have not responded to other treatments, according to a study published in the April 14 online edition of the journal Lancet. Raltegravir works by blocking an HIV enzyme called integrase. Integrase is one of the three enzymes necessary for HIV to replicate in the body, and integrase inhibitors stop HIV from inserting its genes into uninfected DNA. The other two enzymes necessary for viral replication, reverse transcriptase and protease, already are targeted by a variety of antiretroviral drugs.
Merck said that if the drug is approved, it will be used in combination with standard oral antiretrovirals by HIV-positive people who have developed resistance to their current treatments. The company said it will begin filing marketing applications outside the U.S. Raltegravir will be sold under the brand name Isentress (Kaiser Daily HIV/AIDS Report, 6/29).
According to documents posted to FDA's Web site, the panel plans to assess the safety and efficacy of raltegravir on Sept. 5 (AP/Yahoo! Finance News, 7/11).