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CHMP Recommends Expanded Use Of ISENTRESS(R) (Raltegravir), From MSD, In Adult Patients With HIV-1 Infection

Merck Sharp & Dohme Limited (MSD) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending expanded marketing authorisation for "Isentress" (raltegravir) in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in all appropriate adult patients, including patients starting HIV therapy for the first time (treatment-naç¯ve), as well as treatment-experienced patients. The positive opinion will be reviewed by the European Commission, which grants marketing authorisation to the 27 countries that are members of the European Union (EU), as well as Iceland and Norway. Raltegravir, the first and only approved integrase inhibitor, is currently approved in more than 80 countries across six continents for use in combination with other ARV agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of HIV-1 replication despite ongoing ARV therapy1. If marketing authorisation is granted by the European Commission, the drug will be approved for use both in treatment-naç¯ve and treatment-experienced patients. About Raltegravir Raltegravir works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity2. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells2. There are drugs in use that inhibit two other enzymes critical to the HIV-1 replication process - protease and reverse transcriptase - but raltegravir is the only drug approved that inhibits the integrase enzyme3. Raltegravir is a single 400 mg tablet taken twice daily without regard to food. Raltegravir does not require boosting with ritonavir1. References 1. Summary of Product Characteristics 2. Grinsztejn B, Nguyen BY, Katlama C, et al. Safety and Efficacy of the HIV-1 Integrase Inhibitor Raltegravir (MK-0518) in Treatment-Experienced Patients with Multidrug-Resistant Virus: A Phase II Randomised Controlled Trial. The Lancet 2007; 369:1261-1269. 3. Hazuda DJ, Felock P, Witmer M, et al. Inhibitors of strand transfer that prevent integration and inhibit HIV-1 replication in cells. Science 2000; 287:646-50. Merck Sharp & Dohme Limited


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