An AIDS drug being developed by ViiV Healthcare will get speedier review from the 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.
ViiV, is a joint venture comprised of three drug firms: GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Japan’s Shionogi. ViiV maintains its U.S. headquarters at GSK’s campus in Research Triangle Park.
Market approval for dolutegravir could be a major win for ViiV because it could shake up the AIDs drug market. It would 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.
GSK holds the largest stake in ViiV. October, the companies said Shionogi will get a 10 percent stake in ViiV, with GSK owning 76.5 percent and Pfizer 13.5 percent.
(Bloomberg News contributed to this report)