Merck & Co's Isentress gets nod from CHMP

Merck, Sharpe & Dohme, the UK subsidiary of US drug major Merck & Co, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for the approval of Isentress (raltegravir) in combination with other antiretroviral medicinal drugs for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

If approved, the agent will be the first integrase inhibitor, a new class of ARTs that works by targeting the integrase enzyme, which is essential for HIV replication. According to MSD, the CHMP gave its positive opinion based on safety and efficacy data from two double-blind, placebo-controlled, 24-week, trials in treatment-experienced patients in which the drug, in combination with optimized background therapy provided significant reductions in HIV RNA viral load (p<0.001), as well as increases in CD4 cell counts (p<0.001).