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news.Merck & Co has announced that the FDA has accepted the supplemental new drug application or sNDA filing for Isentress tablets for standard review.
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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.
The company is seeking US marketing approval of Isentress in combination with other HIV medicines for treatment in adult patients who are previously untreated for HIV. Merck expects FDA action in July 2009.
Peter Kim, president of Merck Research Laboratories, said: “Merck has a long-standing commitment to the R&D of novel treatments for patients infected with HIV. 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.”