Glaxo Wins U.S. FDA Approval for New Daily HIV Therapy

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 two other drugmakers.

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 Food and Drug Administration said in a statement.

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. London-based Glaxo’s medicine is used in combination with other antiretroviral drugs. Merck & Co. makes the first and only other approved integrase strand transfer inhibitor, Isentress, cleared in 2007 and with sales of $1.5 billion last year.

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

About 1.1 million Americans have HIV, the virus that causes AIDS, and 50,000 become infected each year, according to the U.S. Centers for Disease Control and Prevention. About 15,500 died from the disease in 2010, the FDA said in its statement.

New Efforts

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.

Tivicay also is approved for children 12 years and older that weigh at least 40 kilograms (88 pounds), though not those who have taken other drugs in the same class.

ViiV is an independent company that is a joint venture of Glaxo, New York-based Pfizer Inc. and Osaka, Japan-based drugmaker Shionogi & Co. Glaxo owns 76.5 percent of ViiV while Pfizer has a 13.5 percent stake and Shionogi holds 10 percent, Glaxo said.

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