Published in AIDS Weekly, July 25th, 2005
Accelerated approval is a regulatory process that expedites the approval of therapies for serious or life-threatening illnesses that provide meaningful benefit to patients over existing treatments. This approval is based on 24-week data from ongoing studies. Longer term data will be needed before FDA can consider traditional approval for Aptivus. There are no study results demonstrating the effect of Aptivus on clinical progression of HIV-1.
The approved dose of Aptivus is 500 mg...
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