FDA Accepts NDA for Gout Combo Drug

FDA has accepted for review an Ironwood Pharmaceuticals NDA for Duzallo (fixed-dose combination of lesinurad and allopurinol) for treating hyperuricemia in patients with uncontrolled gout. The user fee target action date is expected in the second half of the year.  

Lesinurad is a once-daily oral tablet that lowers serum uric acid by reducing reabsorption of uric acid, thereby increasing renal excretion of uric acid, according to the company. Allopurinol is a xanthine oxidase inhibitor that reduces both the serum and urinary uric acid levels by inhibiting the formation of uric acid.

Ironwood says the submission is based on the extensive clinical program that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared to co-administration of separate lesinurad and allopurinol tablets. The efficacy and safety of the two drugs co-administered separately was demonstrated in two pivotal Phase 3 clinical trials, CLEAR 1 and CLEAR 2, it says.