GSK's HIV-1 drug secures USFDA approval
GlaxoSmithKline Plc’s drug, Tivicay, targeted at HIV-1 secures USFDA approval.
New Delhi, August 13, 2013: The US Food and Drug Administration approved GlaxoSmithKline Plc’s drug, Tivicay, targeted at HIV-1, the most common strain of the virus that causes AIDS.
Generically known as dolutegravir, the drug is intended to be taken daily in combination with other HIV drugs. It may be noted here that Tivicay, which interferes with one of the enzymes necessary for the virus to multiply, can be used to treat infected adults.
The USFDA has also approved the use of this drug for children aged 12 years and over, weighing 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.