BioCentury
ARTICLE | Clinical News

Tivicay dolutegravir regulatory update

August 19, 2013 7:00 AM UTC

FDA approved an NDA from ViiV Healthcare for Tivicay dolutegravir to treat HIV infection in combination with other antiretroviral agents in treatment-naïve and treatment-experienced patients ages >=12 years. The drug had Priority Review and is the first from ViiV's pipeline to be approved. In pediatric patients, the drug is indicated in those weighing >=40 kg who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors. ViiV expects dolutegravir to be available within 2 weeks of the Aug. 12 announcement. The wholesale acquisition cost is $1,175 per month for once-daily dosing with a 50 mg tablet. The HIV integrase inhibitor is also under review in the EU and Canada. ViiV is a JV between GlaxoSmithKline plc (LSE:GSK; NYSE:GSK, London, U.K.) and Pfizer Inc. (NYSE:PFE, New York, N.Y.). ...