13th Nov 2020 14:34
(Alliance News) - The Committee for Medicinal Products for Human Use of the European Medicines Agency on Friday issued a positive opinion for ViiV Healthcare's Tivicay tablets, which is a treatment for children living with HIV.
ViiV Healthcare is the global specialist HIV company majority-owned by GlaxoSmithKline PLC, with Pfizer Inc and Shionogi Ltd as shareholders.
GSK noted Tivicay 5 milligrams dispersible tablets, are used in combination with other antiretroviral agents. They are used for the treatment of human immunodeficiency virus type 1 infection in paediatric patients aged at least four weeks and weighing at least 3 kilograms.
ViiV Chief Executive Deborah Waterhouse said: "Clinical studies in paediatric populations are challenging and it is only with the support of our dedicated research partners that we are able to reach milestones like these. This CHMP positive opinion paves the way to expand the use of dolutegravir in a younger population because this tablet can be dispersed in water, making it much easier for a child to take their medication."
The CHMP's positive opinion is based on data from the ongoing P10934 and ODYSSEY5 studies, which are being conducted in collaboration with international paediatric research networks, IMPAACT and PENTA-ID, GSK noted.
The positive opinion follows the US Food & Drug Administration paediatric indication approval earlier in 2020, expanding the use of Tivicay by providing an age-appropriate formulation to a younger population to help to close the gap between HIV treatment options available for adults and children.
Shares in GSK were down 1.0% in London on Friday afternoon at 1,423.20 pence each. Pfizer was trading 0.5% higher in early trade in New York at USD37.73.
By Paul McGowan; [email protected]
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