August 21, 2017
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FDA Approves Duzallo for Treatment of Hyperuricemia in Patients With Uncontrolled Gout

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The FDA has approved Ironwood Pharmaceuticals’ Duzallo, a combination pill of lesinurad and allopurinol, for the treatment of hyperuricemia in patients with uncontrolled gout, according to a company press release.

“The approval of Duzallo provides a new fixed-dose and dual-mechanism treatment option to help patients with uncontrolled gout achieve target serum uric acid levels. This represents an important and needed new option in the treatment of hyperuricemia,” Michael A. Becker, MD, from the University of Chicago, and colleagues wrote. “Gout is a serious and potentially progressive and debilitating inflammatory disease.”

Duzallo was approved as a once-daily oral treatment for patients who could not achieve their target serum uric acid level with allopurinol alone. The pill is not recommended for treatment of asymptomatic hyperuricemia.

“Getting patients with gout to serum urate goal, and keeping them at or below goal, are essential to success in treating these patients,” Becker said. “Duzallo will help reduce the significant unmet need among patients in the U.S. who fail to get their serum uric acid levels to goal despite taking allopurinol alone.”

 

Reference:

http://news.ironwoodpharma.com/phoenix.zhtml?c=228069&p=irol-newsArticle&ID=2294774