cGMPs

GSK Wins U.S. FDA Approval for HIV Blockbuster

Source: PharmaManufacturing.com

Aug 13, 2013

Bloomberg

GlaxoSmithKline Plc won U.S. regulatory approval for a daily pill against the deadly HIV infection that was developed by ViiV Healthcare Ltd., its joint venture with Pfizer and Shionogi.

Glaxo’s Tivicay can be used by adults with HIV who have never been treated for the virus and those who have previously received drugs to attack the illness. The medicine, known as dolutegravir, is an integrase strand transfer inhibitor that interferes with the enzymes necessary for HIV to multiply.

The FDA is encouraging drugmakers to develop therapies for treatment-experienced HIV patients who develop resistance to medicines on the market. The HIV virus can mutate to outsmart treatments and leaves some patients, typically older ones that have had the disease for a while, few options for survival. The agency drafted guidance in June that, once made final, will reduce clinical trials for HIV drugs to treat patients with resistance.

Glaxo’s Tivicay is used in combination with other antiretroviral drugs. Tivicay reduced the HIV virus to undetectable levels in more people than Gilead Sciences Inc.’s Atripla, the world’s best-selling AIDS drug, in a clinical trial released last year. This is GlaxoSmithKline's fourth new drug approval this year. Read more