FDA accept Merck & Co's sNDA for Isentress

The US Food and Drug Administration has accepted the supplemental New Drug Application filing for drug major Merck & Co's Isentress (raltegravir) tablets for standard review. The company is seeking US marketing approval of its product in combination with other HIV medicines for treatment in adult patients who are previously untreated for HIV. Merck expects FDA action in July 2009.

"Merck has a long-standing commitment to the R&D of novel treatments for patients infected with HIV," said Peter Kim, president of Merck Research Laboratories, adding: "based on the results of our clinical program in treatment-naive patients, we are very enthusiastic about the prospect that Isentress may now have application in the broader HIV community."

The Merck drug is approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents. This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of Isentress, the first medicine to be approved in a new class of antiretroviral drugs called integrase inhibitors.