Gout Drug Approved for Patients with Hyperuricemia

Today, the FDA granted approval to Duzallo (lesinurad and allopurinol) to treat hyperuricemia among patients with uncontrolled gout. The drug is indicated for patients who have not achieved serum uric acid (sUA) levels with allopurinol monotherapy, according to a press release.

The manufacturer, Ironwood Pharmaceuticals, advises that Duzallo is not recommended for patients with gout with asymptomatic hyperuricemia.

Gout is a painful form of inflammatory arthritis that results from hyperuricemia, which can have long-term health effects.

Duzallo is the first therapy that combines allopurinol—the standard treatment for hyperuricemia associated with gout—with the most recently approved drug for the condition, lesinurad, according to the release.

The fixed-dose combination therapy provides a dual mechanism of action that can modify the cause of hyperuricemia.

“The approval of Duzallo provides a new fixed-dose and dual-mechanism treatment option to help patients with uncontrolled gout achieve target sUA levels. This represents an important and needed new option in the treatment of hyperuricemia,” Michael A. Becker, MD, professor emeritus of medicine, Department of Medicine, The University of Chicago, Chicago, IL, said in a press release. “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 US who fail to get their sUA levels to goal despite taking allopurinol alone.”

The approval of Duzallo was based on positive findings from the clinical program for lesinurad (Zurampic) and a pharmacokinetic trial exploring the bioequivalence of Duzallo compared with the co-administration of the drugs.

The phase 3 clinical trials supporting the approval of lesinurad included patients with gout who did not target sUA levels on allopurinol monotherapy.

The investigators found that Duzallo nearly doubled the number of patients who achieved the sUA target of <6-mg/dL at 6 months, according to the study. Duzallo was also found to lower the mean sUA level to <6-mg/dL after 1 month, which maintained for 12 months.

Common adverse events include headache, influenza, higher levels of blood creatinine, and heartburn.

“With Duzallo, nearly twice as many patients with uncontrolled gout may be able to achieve target sUA 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.”