U.S. News

FDA Grants Priority Review Status to Merck's Antiretroviral Raltegravir

June 29, 2007

Merck on Wednesday announced that FDA has granted priority review status to its experimental integrase inhibitor raltegravir, Reuters Health reports. According to Reuters Health, the agency will review Merck's application within six months rather than the standard 10 to 12 months (Reuters Health, 6/27).

Raltegravir, formerly known as MK-0158, 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 (Kaiser Daily HIV/AIDS Report, 4/17).

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 (Reuters Health, 6/27). The company said it will begin filing marketing applications outside the U.S. Raltegravir will be sold under the brand name Isentress (AP/Houston Chronicle, 6/27).

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