US approval for new three-drug combination pill

11 August 2011

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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.

Glossary

reverse transcriptase

A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs).

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA.

first-line therapy

The regimen used when starting treatment for the first time.

European Medicines Agency (EMA)

Regulatory agency that evaluates medicines for safety and efficacy in Europe, performing a similar role to the Food and Drug Administration (FDA) in the United States. The EMA recommends to the European Commission that a medicine can be marketed in the European Union and European Economic Area.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

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.

US approval for new three-drug combination pill

Glossary

reverse transcriptase

nucleoside

first-line therapy

European Medicines Agency (EMA)

Food and Drug Administration (FDA)

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