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CHMP Recommends Expanded Use of ISENTRESS® (raltegravir), from
MSD, in Treatment-Naïve Adult Patients with HIV-1 Infection
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WHITEHOUSE STATION, N.J., U.S.A., 24 July 2009 - Merck Sharp & Dohme (MSD) today 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-naïve patients is investigational and not currently licensed in this patient group.
Notes to Editor
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.
About MSD
Merck & Co., Inc., Whitehouse Station, N.J., U.S.A., which operates in many countries as MSD (Merck Sharp & Dohme), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck & Co., Inc. currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck & Co., Inc. medicines but help deliver them to the people who need them. Merck & Co., Inc. also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
ISENTRESS® is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.
Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck & Co., Inc. undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck & Co., Inc.'s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck & Co., Inc.'s Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
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