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US approval for new three-drug combination pill
Keith Alcorn, 2011-08-11 15:30:00

The US Food and Drug Administration has approved Complera, a combination pill containing three drugs, including the new non-nucleoside reverse transcriptase inhibitor rilpivirine.

Complera combines tenofovir and emtricitabine (FTC) (also available as the combination pill Truvada) with rilpivirine (recently approved in the United States as Edurant). Complera is taken once daily, and is suitable only for patients who have not taken HIV drugs before.

Complera is marketed by Gilead Sciences, but is a joint venture with Johnson & Johnson, which developed rilpivirine. Gilead already markets another once-daily three drug combination, Atripla, which is currently the most commonly prescribed first-line HIV treatment. However, according to Reuters, Gilead will earn more from Complera due to a royalties deal which allows it to retain 30% of the royalty it would otherwise pay to Johnson & Johnson.

Marketing approval in Europe is likely to follow by the first quarter of 2012.

Other recent approvals

Boehringer-Ingelheim received a recommendation for approval of the once-daily, delayed release version of nevirapine (Viramune) from the European Medicines Agency in late July, while Merck received European Union marketing approval for its hepatitis C protease inhibitor boceprevir (Victrelis) earlier this month.