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