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FDA approves Ironwood's combination gout treatment

Published on 22/08/17 at 09:38am

Ironwood Pharmaceuticals has announced that the FDA has approved its drug Duzallo for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone.

While the drug was given the go-ahead in this indication, the FDA noted that it is not suitable for asymptomatic hyperuricemia.

Ironwood claims that Duzallo is the first available treatment which combines allopurinol, the current standard of care for the illness, with lesinurad, the most recent FDA-approved treatment in the disease area. The combination of these two elements in a once-daily oral treatment tackles both overproduction and underexcretion of serum uric acid, the two main causes of the condition.  

The FDA’s decision to approve the drug was based on a pharmacokinetic study comparing the fixed dose combination of lesinurad and allopurinol to the co-administration of the two drugs separately, as well as a trial supporting the new drug application of lesinurad. The data showed that the combination almost doubled the amount of patients who achieved sUA target levels after six months compared to allopurinol alone.

“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,” said Michael A. Becker, Professor Emeritus of Medicine, Department of Medicine, at the University of Chicago. “Gout is a serious and potentially progressive and debilitating inflammatory disease. Getting patients with gout to serum urate goal, and keeping them at or below goal, are essential to success in treating these patients. 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.”

“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,” said Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood. “We believe Duzallo will be the critical driver behind Ironwood’s gout franchise, which is expected to exceed total annual US peak sales of $300 million.”

Ironwood plans for Duzallo to be available to patients by the end of the year.

Matt Fellows

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