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Glaxo, Pfizer’s ViiV Wins Approval for HIV Combo Drug

ViiV Healthcare Co., a joint venture of GlaxoSmithKline Plc, Pfizer Inc. and Shionogi & Co., won U.S. approval for an HIV treatment that combines three drugs into one, reducing side effects and providing greater convenience for patients.

The Food and Drug Administration cleared Triumeq for patients who have no past history of resistance to any of its component drugs, according to a statement ViiV posted today on its website.

Triumeq is made up of London-based Glaxo’s Tivicay, developed by ViiV, and the medicines abacavir and lamivudine. Tivicay was approved in August 2013 and may top $1 billion in sales in 2016 for Glaxo, rising to $2.2 billion in 2018, according to the average of eight analysts’ estimates compiled by Bloomberg. The estimates include Triumeq since the fixed-dose combination is based on Tivicay, according to Leerink Partners.

“We are proud to announce this important milestone, marking the second new treatment to be approved in the U.S. from our pipeline of medicines,” Dominique Limet, ViiV’s chief executive officer, said in the statement.

HIV, or human immunodeficiency virus, can lead to AIDS, which decimates immune systems. More than 1.1 million Americans are living with HIV, according to the Centers for Disease Control and Prevention. Treatment has involved a cocktail of drugs, making single-tablet combinations more convenient.

Tivicay is in a class of drugs called integrase inhibitors that interfere with one of the enzymes required for HIV to multiply. Triumeq is the second HIV single-dose regimen with an integrase inhibitor to hit the market after Stribild from Foster City, California-based Gilead Sciences Inc.

Stribild generated $539 million in sales last year for Gilead and analysts’ estimate the revenue will rise to $1.1 billion this year. Stribild is only for patients who haven’t been treated before.

Gilead is the largest manufacturer of AIDS medicines, including Atripla, the best-selling drug to treat the virus that can be used alone or with other antiretrovirals.

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