Duzallo is created to treat those patients whose serum uric acid levels are not adequately controlled with allopurinol or other xanthine oxidase inhibitos alone - a patient population Ironwood estimates numbers roughly two million in the U.S. The pill is not recommended for treatment of asymptomatic hyperuricemia. Hyperuricemia, or elevated serum uric acid levels in the blood, can lead to gout and painful flares.
Duzallo combines the standard of care treatment, allopurinol, with Ironwood's lesinurad to treat inefficient excretion and overproduction of uric acid in gout patients. "This represents an important and needed new option in the treatment of hyperuricemia", said Michael A. Becker, M.D., professor emeritus of medicine, Department of Medicine, The University of Chicago, Chicago, IL. "DUZALLO will help reduce the significant unmet need among patients in the USA who fail to get their serum uric acid levels to goal despite taking allopurinol alone".
Duzallo was approved as a once-daily oral treatment for patients who could not achieve their target serum uric acid level with allopurinol alone.
McCourt added that Ironwood expects Duzallo to serve as a "critical driver" of its gout franchise, which is expected to exceed total annual US peak sales of $300 million.
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The FDA approval of DUZALLO was based on the clinical program supporting the ZURAMPIC (lesinurad) new drug application (NDA) and a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared to co-administration of separate lesinurad and allopurinol tablets.
Ironwood Pharmaceuticals announces FDA approval of Duzallo (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout [news release].
Duzallo will carry a black box warning for the risk of acute renal failure associated with the use of Zurampic. It is also available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
The DUZALLO NDA was submitted by Ardea Biosciences, Inc. on behalf of Ironwood.
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