FDA Panel To Review Merck's Antiretroviral Raltegravir
Merck's Antiretroviral Raltegravir
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 statusto raltegravir, an experimental integrase inhibitor. Raltegravireffectively decreases HIV viral loads after 24 weeks of use amongHIV-positive people who have not responded to other treatments,according to a study published in the April 14 online edition of thejournal Lancet.
Raltegravir works by blocking an HIVenzyme called integrase. Integrase is one of the three enzymesnecessary for HIV to replicate in the body, and integrase inhibitorsstop HIV from inserting its genes into uninfected DNA. The other twoenzymes necessary for viral replication, reverse transcriptase andprotease, already are targeted by a variety of antiretroviral drugs.
Mercksaid that if the drug is approved, it will be used in combination withstandard oral antiretrovirals by HIV-positive people who have developedresistance to their current treatments. The company said it will beginfiling marketing applications outside the U.S. Raltegravir will be soldunder 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).
Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . TheKaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service ofThe Henry J. Kaiser Family Foundation.