Positive Opinion From CPMP For Abbott's Norvir

Abbott Laboratories has been granted a positive scientific opinion for a European Marketing Authorization for its HIV protease inhibitor Norvir (ritonavir) for use in combination with antiretroviral nucleoside analogues for the treatment of HIV-infected adult patients with advanced or progressive immunodeficiency. The opinion comes from the European Medicines Evaluation Agency via its scientific Committee for Proprietary Medicinal Products.

Abbott says that Norvir is the first HIV protease inhibitor to receive a scientific approval from the CPMP, and notes that the product is currently pending a final marketing approval by the European Commission in Brussels. The product has already been launched in the USA (Marketletter March 11). Other protease inhibitors which are already on the market include Hoffmann-La Roche's Invirase (saquinavir) and Merck & Co's Crixivan (indinavir).

The scientific approval is in part based on the results of a study in patients with advanced HIV infection which showed a decrease in mortality, as well as illnesses frequently encountered in HIV-infected patients, in those receiving Norvir. Norvir is the only protease inhibitor to have clinical endpoint data as part of its approval dossier, but even so little information is available beyond six months. Studies have also demonstrated a decrease in the amount of the human immunodeficiency virus measurable in the blood as well as an increase in CD4 cells in patients given Norvir.