FDA report supports Merck HIV drug approval

The document, which reviews current data on Isentress (raltegravir), said that “the benefits of raltegravir in HIV-1 treatment-experienced subjects outweigh the currently identified risks.” The drug is currently being evaluated in a Phase III study in treatment-naive patients.

Raltegravir is the first agent of the pharmacological class of antiretroviral agents known as integrase inhibitors to be submitted to FDA for review for marketing approval. The drug works by blocking one of the processes whereby HIV replicates itself.

The FDA analyses of the safety and efficacy data submitted in the NDA support Merck’s findings, the document said. Phase II and III trial data provide evidence that the antiviral activity of raltegravir is superior to optimized background therapy in treatment-experienced patients with few or no remaining treatment options. The report concluded that raltegravir appeared to be well-tolerated in the Phase II and Phase III clinical studies with relatively few subjects discontinuing for adverse events.

The advisory committee will take the report into consideration when it meets to make its recommendations on approving the drug on September 5.