Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Admi...( - Additional Data Submitted to...),Health

- Additional Data Submitted to FDA for Traditional Approval -

YARDLEY, Pa., Dec. 21 /PRNewswire/ -- Tibotec, Inc. today announced it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the protease inhibitor (PI) PREZISTA(TM) (darunavir) tablets, which seeks traditional approval and an expanded indication to include human immunodeficiency virus (HIV)-1-infected, treatment-naive adults. The application includes 48-week data from two Phase 3 studies, ARTEMIS and TITAN, which were presented at HIV conferences earlier this year, as well as 96-week data from the Phase 2b studies, POWER 1, 2, and 3.

PREZISTA received accelerated approval in June 2006 based on the 24-week analysis of HIV viral load and CD4+ cell counts from the pooled analysis of the TMC114-C213 (POWER 1) and TMC114-C202 (POWER 2) Phase 2b studies. As part of the post-marketing commitment, 48-week data from ongoing Phase 3 studies (ARTEMIS and TITAN) and 96-week data from POWER 1, 2, and 3 are required before the FDA can consider traditional approval for PREZISTA.

PREZISTA, co-administered with 100 mg ritonavir and with other antiretroviral agents, is currently indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from two controlled trials of PREZISTA/ritonavir (PREZISTA/r) in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with PREZISTA/r:

-- Treatment history and, when available, genotypic or phenot
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