GlaxoSmithKline plc’s (NYSE:GSK) (LON:GSK) drug dolutegravir has been granted priority review status by the U.S. Food and Drug Administration. The HIV/AIDS drug is an integrase inhibitor which keeps the HIV virus from going into cells. The drug is owned by the joint venture ViiV Healthcare, and GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) is the largest shareholder.
Drugs receive priority status if U.S. officials believe they could greatly improve treatments that are currently being used. The FDA is expected to issue its decision on whether dolutegravir is approved for use by Aug. 17.
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Reuters reports that thus far the drug has shown positive results in clinical trials. The results have been so positive that GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) has redrawn its agreement with the Japanese drug maker Shionogi & Co Ltd (TYO:4507).
The new agreement gives Shionogi & Co Ltd (TYO:4507) a 10 percent stake in the joint venture in exchange for the company’s shared rights to the HIV/AIDS drug. As a result of that agreement, GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) owns 76.5 percent of the joint venture, while Pfizer Inc. (NYSE:PFE) owns 13.5 percent and Shinogi owns 10 percent.
Industry experts believe dolutegravir will become a strong competitor to Gilead Sciences’ HIV treatments, which are currently the most popular treatments for the disease. They believe the drug could bring billions of dollars in sales for GlaxoSmithKline plc (NYSE:GSK) (LON:GSK) if it is approved and then distributed for treatments.
Meanwhile GlaxoSmithKline’s consumer healthcare division reported an 18 percent increase in net profits for its fourth quarter.