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.
This report is also available in Portuguese.