HIV/AIDS
FDA Priority Review Granted for ISENTRESS (raltegravir), Merck's Investigational Integrase Inhibitor for HIV
Published in Medical Letter on the CDC and FDA, July 15th, 2007
Merck & Co., Inc. (NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ISENTRESS(TM) (raltegravir, previously known as MK-0518). Data in the NDA support the proposed use of ISENTRESS in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy (ART).
The FDA granted ISENTRESS priority review status, a designation for investigational products that address unmet medical needs. Under the priority review designation, the FDA is expected to review and act on the NDA for ISENTRESS...
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