FDA approves GSK's HIV-1 drug
Aug 12 (Reuters) - The U.S. Food and Drug Administration approved Tivicay, GlaxoSmithKline Plc's drug targeted at HIV-1, the most common strain of the virus that causes AIDS.
The drug, known generically as dolutegravir, is intended to be taken daily in combination with other HIV drugs.
Tivicay, which interferes with one of the enzymes necessary for the virus to multiply, can be used to treat infected adults who have been treated with other drugs or are new to treatment.
The FDA also approved the use of the drug for children aged 12 years and over, who weigh at least 40 kilograms and who have not received treatment that has the same mechanism as the drug.
Tivicay was tested in adults in four clinical trials in combination with other antiretroviral drugs, and in one trial involving children.
The FDA's decision comes a few days after it approved Alere Inc's test for two types of HIV.