EMA Accepts MAA of AstraZeneca’s Gout Drug
AstraZeneca reports that the European Medicines Agency has accepted the marketing authorization application (MAA) for lesinurad 200 mg tablets, a drug to treat gout. Lesinurad is a selective uric acid reabsorption inhibitor (SURI) developed for the chronic treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors, allopurinol or febuxostat, in gout patients when additional therapy is warranted.
Ardea Biosciences, Inc., which was acquired by AstraZeneca in June 2012, is leading the development of AstraZeneca's gout portfolio, including lesinurad and RDEA3170.,
Lesinurad works by inhibiting the uric acid transporter URAT1 in the kidney, thereby increasing uric acid excretion, resulting in lower serum uric acid (sUA) levels. Combination therapy with lesinurad and an XO inhibitor provides a dual mechanism approach targeting both excretion and production of uric acid to lower sUA. Lesinurad also inhibits OAT4, a uric acid transporter involved in diuretic-induced hyperuricaemia.