FDA reviews the dual-mechanism treatment for gout

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FDA reviews the dual-mechanism treatment for gout

The new drug application (NDA) for lesinurad/allopurinol fixed-dose combination, an ironwood for the treatment of hyperuricemia in with uncontrolled gout has been accepted for review by the Food and Drug Administration (FDA).

The data from the lesinurad, Ironwood clinical trial program and a pharmacokinetic study gave away to the NDA submission for lesinurad/allopurinol inspecting the bioequivalence of the fixed-dose combination compared to lesinurad and allopurinol co-administered separately.

The results of this study revealed that the addition oflesinurad to a xanthine oxidase inhibitor (XOI) almost doubled the number of patients who accomplished target serum uric acid (sUA) levels of <6mg/dL at month 6. Also, the fixed-dose combination reduced the mean sUA to <6mg/dL by month 1 and sustained that level through month 12.

Recently, Lesinurad a URAT1 inhibitor, was approved in combination with a XOI for the treatment of hyperuricemia associated with gout in patients. These did not achieve target serum uric acid levels with a XOI alone. It increases the renal excretion of uric acid through the selective inhibition of URAT1- the transporter responsible for the majority of renal uric acid reabsorption. Allopurinol is a XOI which decreases the production of uric acid. As a combination product,  exercise this dual-mechanism which can address both the inefficient excretion and the overproduction of uric acid.

The FDA anticipated the Prescription Drug User Fee Act target action on Aug 18, 2017. It has been approved as the first gout treatment in a daily fixed-dose combination possessing the dual mechanism of action. 



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The original title of the article:

Dual-Mechanism Gout Treatment Under FDA Review

Therapeutic, Lesinurad/allopurinol fixed-dose combination, FDA, URAT1 inhibitor, XOI, NDA, Gout
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