Label of Gilead's Complera Expanded


Good news flowed in at Gilead Sciences, Inc. (GILD) when the U.S. Food and Drug Administration (:FDA) approved its HIV single tablet regimen Complera (once daily) for an additional indication. Gilead gained FDA approval of Complera in certain virologically-suppressed (HIV RNA
Approval was gained on the basis of encouraging data from a phase III open-label, randomized study (SPIRIT: study 106). Complera, a fixed-dose combination of Gilead’s Truvada (which in turn is a fixed-dose drug of Gilead's Viread and Emtriva) and Johnson and Johnson’s (JNJ) Edurant, was initially launched in the U.S. in 2011 as a first-line therapy for HIV. Following the label expansion, HIV infected adults can switch to Complera therapy from other treatment regimens.

Complera is marketed as Eviplera in the EU since 2011 as a first-line therapy in HIV infected adults. Currently, the regimen is also approved in the EU for treating HIV infected adults without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor class, Gilead’s Viread or Emtriva. Moreover, the viral load is less than or equal to 100,000 HIV-1 RNA copies/mL.

Approval of Complera/ Eviplera for the new indication will further boost the drug’s sales potential. The combination drug has performed well since launch with sales in the third quarter of 2013 climbing 12% sequentially to $210.7 million.

Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Actelion Ltd. (ALIOF) and Vanda Pharmaceuticals Inc. (VNDA). Both stocks carry a Zacks Rank #1 (Strong Buy).

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