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FDA approves once-daily HIV treatment Complera

The FDA approves Johnson&Johnson/Gilead’s once daily, single tablet regime HIV-1 treatment, Complera

The US Food and Drug Administration (FDA) has approved Complera, a once-daily HIV treatment.

Complera is for the treatment of HIV-1 infection in treatment-naive adults, and works through combining Johnson & Johnson and Tibotec's Edurant (rilpivirine) and Gilead's Truvada (tenofovir/emtricitabine).

FDA approval was granted due to data gained from the late-stage ECHO and THRIVE studies. A bioequivalence study demonstrated that when compared to tenofovir and emtricitabine and rilpivirine, Complera achieved the same levels of medication in the blood.

Complera is expected to generate around $567m in revenue in 2013 according to Lazard Capital Markets analyst Joel Sendek, who referred to the drug as a “catalyst”.

Complera is the “second complete antiretroviral treatment for HIV-1”, that is available in a single tablet regimen.

11th August 2011

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