The U.S. Food and Drug Administration has approved Ironwood Pharmaceuticals Inc.'s drug Duzallo, a once-daily oral treatment to fight hyperuricemia associated with gout in patients.
Specifically, the drug targets those patients who have been using allopurinol alone and have not achieved proper serum uric acid (sUA) levels.
“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," Dr. Michael Becker, professor emeritus of medicine at the University of Chicago, said in a statement. "This represents an important and needed new option in the treatment of hyperuricemia."
Becker noted that gout can cause serious and debilitating issues, and those battling it must reach proper serum urate goals. That is where Duzallo comes into the picture.
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, Becker said.
“With DUZALLO, nearly twice as many patients with uncontrolled gout may be able to achieve target serum uric acid levels compared to those patients taking allopurinol alone, which is important, considering the significant unmet need among uncontrolled gout patients to get to goal of under 6 mg/dL,” Tom McCourt, senior vice president of marketing and sales at Ironwood, said.
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