AEGiS-FDA: Traditional approval of Aptivus (tipranavir)

Important note: Information in this article was accurate in 2007. The state of the art may have changed since the publication date.

Traditional approval of Aptivus (tipranavir)

Food and Drug Administration - October 11, 2007
Richard Klein & Kimberly Struble

On October 4, 2007, FDA granted traditional approval to Aptivus (tipranavir), for combination antiretroviral treatment of HIV-1 infected adults with evidence of viral replication, who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor. Aptivus was granted accelerated approval on June 22, 2005, based on analysis of plasma HIV-1 RNA levels in two controlled phase 3 studies, of 24 weeks duration, of Aptivus/ritonavir. The traditional approval is based on continuation of the RESIST trials through 48 weeks and beyond, confirming durability of the virologic response. Aptivus is a product of Bohringer Ingelheim.

Richard Klein | Office of Special Health Issues | Food and Drug Administration

Kimberly Struble | Division of Antiviral Drug Products | Food and Drug Administration
071011
FD071001

SOURCE: Food and Drug Administration (FDA).

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