Gilead Clarifies Quad Will Come First, Over Detailing For Triple Combo Complera
This article was originally published in Pharmaceutical Approvals Monthly
Company is pursuing priority review, eyes FDA approval in mid-2012. If Quad is cleared, newly approved Complera will take back seat.
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After announcing FDA approval of a new HIV combination last week, Gilead released positive comparative data on the Quad pill Aug. 15.
Antiretroviral combines Gilead's Truvada with J&J's Edurant for HIV, and is intended as a replacement to the existing triple combination Atripla.
By and large, Gilead's latest Phase II results for its fixed-dose, four-drug "Quad" regimen for HIV and stand-alone data on its novel GS-9350 booster satisfied clinicians and analysts when it came to the commercially crucial tolerability test