February 15, 2013
ViiV Healthcare, the HIV joint venture set up by GlaxoSmithKline (NYSE: GSK ) and Pfizer (NYSE: PFE ) , announced today that the Food and Drug Administration has granted its HIV drug, dolutegravir, a priority review.
Priority reviews are given to drugs that offer significant improvement over current treatments, or treat a disease where patients have no current options. The designation shortens the review time to eight months.
ViiV submitted the application on December 12, 2012, so it expects to hear back from the FDA by August 17. The company also submitted an application to market the drug in Europe and Canada on the same day.
Dolutegravir was tested in 2,553 patients with HIV/AIDS in four phase 3 clinical trials. The drug was developed by Japan-based Shionogi, which became a 10% equity owner in ViiV last October.