ViiV’s HIV Treatment Dolutegravir Will Get FDA Priority Review
ViiV Healthcare Ltd., a joint venture of GlaxoSmithKline Plc and two other drugmakers, said its experimental HIV medicine dolutegravir will get a speedier review by the U.S. Food and Drug Administration.
A regulatory decision is scheduled for Aug. 17 after Viiv submitted an application on Dec. 17, the London-based company said in a statement today. The FDA gave dolutegravir priority review status, which is granted to drugs that have the potential to offer significant improvement over existing therapies or where no adequate treatment exists, the company said.
Dolutegravir may challenge the world’s best-selling AIDS medicine, made by Gilead Sciences Inc. The drug, combined with one of ViiV’s older treatments, reduced the HIV virus to undetectable levels in more people than Gilead’s Atripla in a clinical trial released in July. ViiV also submitted an application for European Union approval on Dec. 17.
If approved, dolutegravir would be the second in a new class of HIV medicines called integrase inhibitors that work by blocking HIV’s ability to replicate.
ViiV is Glaxo’s joint-venture with New York-based Pfizer Inc. and Japan’s Shionogi & Co. In October, the companies said Shionogi will get a 10 percent stake in ViiV, with London-based Glaxo owning 76.5 percent and Pfizer 13.5 percent.
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