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JANUARY 4, 2017

FDA to Review New Drug Application for Gout Drug

The FDA is reviewing the New Drug Application (NDA) of a once-daily, fixed-dose combination of lesinurad and allopurinol (Duzallo, Ironwood Pharmaceuticals) for the treatment of hyperuricemia in patients with uncontrolled gout.

Approximately half of the 4 million gout patients in the United States being treated with a xanthine oxidase inhibitor (XOI) are uncontrolled and do not achieve the American College of Rheumatology’s (ACR’s) recommended target serum uric acid (sUA) level of