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news.The FDA has granted Merck & Co.'s Isentress tablets accelerated approval 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.
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This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of Isentress (raltegravir). These studies were conducted in clinically advanced, three-class antiretroviral treatment-experienced adults.
The use of other active agents with Isentress is associated with a greater likelihood of treatment response.
The drug’s safety and efficacy have not been established in treatment-naive adult patients or pediatric patients. Longer-term data will be required before the FDA can consider traditional approval for Isentress.
Peter Kim, president of Merck Research Laboratories, said: “Isentress is the first drug in a new class of antiretroviral therapies that when used in combination with other effective antiretroviral agents, offers a new opportunity for individuals whose HIV infection is no longer adequately controlled and whose virus is resistant to multiple agents. This approval builds on our longstanding commitment to research in HIV/AIDS, with the goal of making truly differentiated therapies available to patients in need.”