FDAnews Drug Daily Bulletin

Gilead’s Complera Wins New U.S. Indication

Dec. 18, 2013

The FDA approved Gilead Sciences’ Complera for HIV-1 patients who have had viral RNA loads of less than 50 copies/mL for at least six months and who are already on a stable dose of antiretrovirals with no history of virologic failure.

The agency based its decision on data from the Phase III SPIRIT trial that showed that after 48 weeks, 89 percent of patients who switched to Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) had a viral load of less than 50 copies/mL compared with 90 percent of patients on their previous regimen at 24 weeks.

The drug combines into a single once-daily pill Janssen’s Edurant (rilpivirine) with Gilead’s Truvada (emtricitabine/tenofovir disoproxil fumarate). It recently received European regulatory approval and is marketed there as Eviplera.

Complera was first approved by the FDA in August 2011 for patients completely new to HIV therapy. Complera/Eviplera raked in $342.2 million in 2012. — Lena Freund

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