15th Jun 2020 06:42
(Alliance News) - ViiV Healthcare on Friday said the US Food & Drug Administration has approved Tivicay PD tablets, an HIV drug, for oral suspension.
ViiV is a specialist human immunodeficiency virus company, majority-owned by GlaxoSmithKline PLC, with Pfizer Inc and Shionogi Ltd as shareholders.
Tivicay PD tablets are used in combination with other antiretroviral agents for the treatment of HIV type 1 infection in paediatric patients aged at least four weeks and weighing at least 3 kilograms, as well as an extended indication to expand the use of the already approved Tivicay tablet in paediatric HIV patients weighing 20 kilograms and above.
The FDA approval is based on data from the ongoing P1093 and Odyssey studies.
"We now need to continue our efforts to ensure this new dispersible formulation is available to children who need it around the world, in line with our mission to leave no person living with HIV behind," said ViiV Chief Executive Deborah Waterhouse.
Glaxo shares closed 1.0% higher on Friday in London at 1,599.20 pence each. Pfizer stock ended up 1.4% in New York at USD33.75 per share, remaining flat in after-hours trading.
By Evelina Grecenko; [email protected]
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