26th Oct 2015 07:26
LONDON (Alliance News) - AstraZeneca PLC on Monday said an advisory committee of the US Food and Drug Administration voted by a majority in favour of its lesinurad drug, in combination with a xanthine oxidase inhibitor, to be approved for the treatment of hyperuricemia associated with gout.
The US FDA's Arthritis Advisory Committee voted in favour by a count of 10 to 4. The FDA is not bound by this vote, but will take it into consideration whilst reviewing the application for the drug.
The drug is also under regulatory review in the European Union and other territories.
"The committee's positive recommendation for lesinurad is an encouraging step for patients suffering from the debilitating effects of gout. We look forward to the outcome of the FDA's review and the opportunity to provide a new treatment option that, when combined with a xanthine oxidase inhibitor, addresses both the under-excretion and over-production of uric acid, the underlying causes of gout," said Sean Bohen, AstraZeneca's executive vice president of global medicines development and chief medical officer, in a statement.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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