CHMP Recommends Expanded Use of ISENTRESS, from MSD, in Adult Patients with HIV-1 Infection
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-naive patients is investigational and not currently licensed in this patient group.
Organizations
Other news from the department research and development

Get the life science industry in your inbox
By submitting this form you agree that LUMITOS AG will send you the newsletter(s) selected above by email. Your data will not be passed on to third parties. Your data will be stored and processed in accordance with our data protection regulations. LUMITOS may contact you by email for the purpose of advertising or market and opinion surveys. You can revoke your consent at any time without giving reasons to LUMITOS AG, Ernst-Augustin-Str. 2, 12489 Berlin, Germany or by e-mail at revoke@lumitos.com with effect for the future. In addition, each email contains a link to unsubscribe from the corresponding newsletter.