Merck Receives Priority Review for Isentress

Merck announced that the FDA accepted its new drug application (NDA) for Isentress for use in combination with other antiretroviral agents to treat HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The FDA granted Isentress (raltegravir) priority review status, Merck said, adding that it anticipates FDA action by mid-October. The company said it is also moving forward with regulatory filings in countries outside of the U.S.

If approved, Isentress would be the first in a new class of antiretroviral agents called integrase-inhibitors that inhibit the insertion of HIV DNA into human DNA. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells, the company said.