Looks like you’re on the UK site. Choose another location to see content specific to your location

Home Industry News Tibotec submits application for Prezista

Tibotec submits application for Prezista

27th December 2007

Tibotec, a division of Johnson & Johnson (J&J), has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for its protease inhibitor Prezista (darunavir).

The application seeks traditional approval for the drug as well as an expanded indication to include human immunodeficiency virus (HIV)-1-infected, treatment-naive adults.

Following two 48-week phase III studies – Artemis and Titan – data was drawn up for the application which was also presented at a series of HIV conferences throughout the year.

Prezista has also been subject to three phase IIb studies, entitled the Power trials and which spanned 96 weeks.

The protease inhibitor received accelerated approval in June 2006 as a result of a 24-week analysis of HIV viral load and CD4+ cell counts from the pooled data of the Power 1 and Power 2 studies.

As part of Tibotec’s post-marketing commitments, 48-week data from ongoing phase III studies (Artemis and Titan) and 96-week data from Power 1, 2 and 3 are required before the FDA can make a decision on approval for Prezista.

Earlier this month, J&J reported new data which showed that its Invega extended-release tablets demonstrated favourable long-term safety and tolerability during a one-year open-label extension study.

We currently have 5 jobs available in Pharmacy industry, find your perfect one now.

Stay informed

Receive the latest industry news, Tips
and straight to your inbox.