FDA Approves Viracept, New Protease Inhibitor

April 1, 1997

ROCKVILLE, Md--The FDA has given Agouron Pharmaceuticals clearance to market its protease inhibitor Viracept (nelfinavir mesylate), under the accelerated approval process. Viracept was approved in both adult and pediatric formulations, for the treatment of HIV when antiretroviral therapy is warranted.

ROCKVILLE, Md--The FDA has given Agouron Pharmaceuticals clearance tomarket its protease inhibitor Viracept (nelfinavir mesylate), under theaccelerated approval process. Viracept was approved in both adult and pediatricformulations, for the treatment of HIV when antiretroviral therapy is warranted.

The indication is based on analyses of surrogate marker changes in patientswho received Viracept in combination with nucleoside analogues or alonefor up to 24 weeks. At present, there are no results from controlled trialsevaluating the effects of Viracept on clinical progression of HIV infection,such as survival or the incidence of opportunistic infections.