9th Nov 2015 13:44
LONDON (Alliance News) - AstraZeneca PLC announced positive subanalysis data of the Phase III lesinurad studies for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. The company said the results demonstrated a consistent efficacy and safety profile in patients with normal renal function, as well as patients with mild to moderate renal impairment.
In October, the US FDA's Arthritis Advisory Committee voted 10 to 4 to recommend the approval of lesinurad 200 mg for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. The PDUFA target goal date for lesinurad is December 29, 2015.
Lesinurad is also under regulatory review in the EU and other territories.
Copyright RTT News/dpa-AFX
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