FDA approves new ViiV Healthcare HIV drug

The US Food and Drug Administration yesterday (August 12) approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection developed by ViiV Healthcare, the HIV/AIDS joint venture set up by UK pharma giant GlaxoSmithKline (LSE: GSK) with US behemoth Pfizer (NYSE: PFE) and Japan’s Shionogi (TYO:4507). The decision comes slightly ahead of the expected August 17 FDA action date.

Tivicay, which gained priority review status from the FDA early this year (The Pharma Letter February 18), is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naive) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children aged 12 years and older weighing at least 40kg who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.

“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, adding: “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”