FDA OKs AstraZeneca’s Gout Drug
The US Food and Drug Administration has approved AstraZeneca’s Zurampic (lesinurad) 200-mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone.
Zurampic inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1,Zurampic increases uric acid excretion and thereby lowers sUA.
Zurampic is also under regulatory review in the European Union and other territories. On December 18, 2015, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization of Zurampic 200-mg tablets.
Ardea Biosciences, a member of the AstraZeneca Group, located in San Diego, California, is leading the development of AstraZeneca's gout portfolio, including Zurampic and RDEA3170. RDEA3170 is a potent selective uric acid reabsorption inhibitor (SURI), also intended for use as a combination urate lowering therapy with xanthine oxidase inhibitors (XOIs). RDEA3170 is the company’s lead investigational urate lowering therapy (ULT) in Asia and is currently entering a Phase IIb trial worldwide.