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

Main Category: HIV / AIDS
Article Date: 27 Jul 2009 - 16:00 PDT


Merck, Sharp & Dohme (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-naïve), 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 therapy. The U.S. Food and Drug Administration recently approved an expanded indication for raltegravir in combination with other antiretroviral medicines for the treatment of HIV-1 infection in adult patients that includes patients starting HIV therapy for the first time, as well as treatment-experienced patients. In markets outside the United States, the use of raltegravir in treatment-naive patients is investigational and not currently licensed in this patient group.

About Raltegravir

Raltegravir works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells. 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 enzyme. Raltegravir is a single 400 mg tablet taken twice daily without regard to food. Raltegravir does not require boosting with ritonavir.

Source
Merck & Co., Inc.

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