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FDA Oks HIV drug from Glaxo-Pfizer joint venture

The Associated Press

Federal regulators have approved a new HIV treatment from ViiV Healthcare, a joint venture between pharmaceutical giants GlaxoSmithKline PLC and Pfizer Inc.

The Food and Drug Administration approved 50-milligram tablets of the drug Tivicay to be combined with other medications for the treatment of HIV-1 in adults and some children, the company said Tuesday. HIV is the virus that causes AIDS.

Tivicay acts as an integrase inhibitor, which blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells. That step also is responsible for establishing chronic infections.

The drug developer said that it submitted to the FDA data from four late-stage clinical studies that treated 2,557 adults and some data from children ages 12 and older.

The British drugmaker GlaxoSmithKline and New York-based Pfizer created ViiV in 2009 to specialize in HIV treatments.