FDA Advisory Committee Recommends AstraZeneca’s Gout Drug
AstraZeneca reports that the US Food and Drug Administration's (FDA) Arthritis Advisory Committee (AAC) has recommended the approval of lesinurad 200mg tablets for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI). The FDA is not bound by the AAC's recommendation but takes its advice into consideration when reviewing the application for a potential medicine. The Prescription Drug User Fee Act (PDUFA) target goal date for lesinurad is December 29, 2015.
Lesinurad is a selective uric acid reabsorption inhibitor, or SURI. It inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid, according to AstraZeneca. Lesinurad is also under regulatory review in the European Union and other territories.
AstraZeneca gained the drug through its 2012 acquisition of Ardea Biosciences, Inc. Ardea is leading the development of AstraZeneca's gout portfolio, including lesinurad and RDEA3170. RDEA3170 is a selective uric acid reabsorption inhibitor, also intended for use as a combination urate lowering therapy with xanthine oxidase inhibitors. RDEA3170 is the company’s lead investigational urate lowering therapy (ULT) in Asia and is currently entering a Phase IIb trial in the US.