LONDON (Alliance News) - GlaxoSmithKline PLC's HIV joint venture ViiV Healthcare said the US Food & Drug Administration has approved its supplemental new drug application to lower the weight limit for dolutegravir for the treatment of HIV-1 in children and adolescents.
It has approved the new drug application for dolutegravier 10 milligram and 25 milligram oral tablets, reducing the weight limit to at least 30 kilograms from at least 40 kilograms, in ages 6 to less than 12 years old.
"From day one children and adolescents have been, and remain, a key focus in our drive to improve outcomes for people living with HIV," said Chief Scientific and Medical Officer at ViiV John Pottage in a statement.
"Through our research and development efforts, corporate social responsibility programmes, partnerships and access initiatives, we have made a difference for younger populations. This approval by the FDA provides more children and adolescents the option to be treated with dolutegravir in the US, and supports the global UNAIDS paediatric treatment target," Pottage added.
ViiV is Glaxo's 76.5%-owned joint venture with the US's Pfizer Inc, which has 13.5%, and Japan's Shionogi Ltd, with 10%.
Shares in Glaxo were down 2.4% at 1,405.32 pence Friday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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