US FDA backs new indication for Gilead's Complera

14 December 2013

US biotech firm Gilead Sciences’ (Nasdaq: GILD) share closed up 1.6% at $71.40 on Friday, following the news of an additional indication in the USA for its single-pill combination HIV treatment for patients switching from a stable regimen.

The company revealed that the US Food and Drug Administration approved the single tablet HIV-1 regimen Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for use in certain virologically-suppressed (HIV RNA <50 copies/mL) adult patients on a stable antiretroviral regimen in order to replace their current antiretroviral treatment regimen.

Complera was approved more than two years ago by the FDA for the treatment of HIV-1 infection in treatment-naive adults (The Pharma Letter August 11, 2011) and is now one of the most widely-prescribed HIV regimens in the USA, generating sales of $547.6 million in the first nine months of 2013, a 144% rise year-on-year.

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