GlaxoSmithKline Plc (GSK)’s HIV drug Tivicay was recommended for approval by the European Union’s drug regulator.
Tivicay won the backing of the Committee for Medicinal Products for Human Use in combination with other antiretroviral medicines for the treatment of HIV patients over the age of 12, the European Medicines Agency said in a statement today. The drug was developed by ViiV Healthcare Ltd., Glaxo’s venture with two other drugmakers.
The treatment, approved by the U.S. Food and Drug Administration in August, reduced the HIV virus to undetectable levels in more people than Gilead Sciences Inc. (GILD)’s Atripla, the world’s best-selling AIDS drug, in a clinical trial released last year. The medicine, also known as dolutegravir, is an integrase strand transfer inhibitor that interferes with the enzymes necessary for HIV to multiply.
Merck & Co. makes the first and only other approved integrase strand transfer inhibitor, Isentress, which was cleared in 2007 and had sales of $1.5 billion last year.
ViiV is an independent company that is a 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, according to Glaxo.
The EMA’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation region. The EC usually follows the committee’s advice.
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