Isentress, which represents the first integrase inhibitor, will be marketed in all member states, and the firm will receive licenses for Norway and Iceland.
The European Union Commission approved Merck & Co. first-in-class HIV therapy Isentress® (Raltegravir). The drug will be marketed for use in combination with other antiretroviral products against HIV-1 infection in treatment-experienced adults with evidence of HIV-1 replication despite ongoing antiretroviral therapy (ART).
The commission’s decision is applicable to the 27 member states of the EU. Separate national licenses will also be issued in European Economic Area member states Iceland and Norway, according to Merck, also known as Merck Sharp & Dohme (MSD) in some countries.
Isentress is already sanctioned in North America. MSD says that it is also moving forward with filings in other countries around the world.
Isentress is the first approved integrase inhibitor. It inhibits the insertion of the HIV DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function blocks the ability of the virus to replicate and infect new cells. Other drugs target the other two enzymes critical to HIV replication, protease and reverse transcriptase. Pfizer’s Maraviroc, on the other hand, which received FDA approval in August, blocks the CCR5 co-receptor.
“Raltegravir is an important new advancement in the treatment of HIV because it is the first therapy in a new class of drugs that attacks the virus in a completely different way from other available medicines,” notes Ken Frazier, evp and president, global human health, Merck.