Merck Announces FDA Acceptance of Supplemental New Drug Application for ISENTRESS® (raltegravir) in Adult Patients Previously Untreated for HIV-1
WHITEHOUSE STATION, N.J., Dec. 12, 2008 - Merck & Co., Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) filing for ISENTRESS® (raltegravir) Tablets for standard review. The Company is seeking United States marketing approval of ISENTRESS in combination with other HIV medicines for treatment in adult patients who are previously untreated (naïve) for HIV. Merck expects FDA action in July 2009.
"Merck has a long-standing commitment to the research and development of novel treatments for patients infected with HIV," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "Based on the results of our clinical program in treatment-naïve patients, we are very enthusiastic about the prospect that ISENTRESS may now have application in the broader HIV community."
ISENTRESS 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. These studies were conducted in clinically advanced, three-class antiretroviral [nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)] treatment-experienced adults. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. The safety and efficacy of ISENTRESS have not been established in treatment-naïve adult patients or pediatric patients. There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
ISENTRESS is the first medicine to be approved in a new class of antiretroviral drugs called integrase inhibitors. ISENTRESS works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. There are drugs in use that inhibit two other enzymes critical to the HIV-1 replication process - protease and reverse transcriptase - but ISENTRESS is the only drug approved that inhibits the integrase enzyme.