Boehringer Ingelheim has won US Food and Drug Administration approval to market its new AIDS drug, Aptivus (tipranavir),
The drug was approved under the accelerated approval process that speeds up the approval of therapies for serious or life-threatening illnesses that are deemed to provide meaningful benefit to patients over existing treatments. This Aptivus green light is based on 24-week data from ongoing studies – longer-term data will be needed before the agency can consider traditional approval for Aptivus.
The product has specifically been given the all clear for use in combination with Abbott Laboratories’ Norvir (ritonavir), on the back of data from the RESIST clinical studies, in which patients taking Aptivus plus Norvir experienced a significantly greater treatment response, versus those given a protease inhibitor regimen [[26/10/04f]].
Aptivus is a protease inhibitor that works by inhibiting the enzyme needed to complete the HIV replication process. BI says that Aptivus is able to enter infected immune cells and inhibit HIV replication for many strains of HIV that are resistant to other commercially available protease inhibitors. Drug resistance is one of the major challenges in the treatment of HIV.
Approval comes just over a month after an FDA advisory panel recommended that the green light be awarded, in spite of committee members saying that the exact usefulness needed to be monitored in the future, and calling for additional studies on long-term liver toxicity [[20/05/05d]].