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This is the first FDA-approved fixed-dose combination treatment that addresses both overproduction and underexcretion of serum uric acid in a single pill.
Duzallo has received FDA approval as a once-daily oral treatment for 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, Ironwood Pharmaceuticals, Inc. announced in a press release. Duzallo is not recommended for treatment of patients with asymptomatic hyperuricemia.
Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout-allopurinol-with the most recent FDA-approved treatment for this condition, lesinurad, the company stated. The fixed-dose combination provides a dual mechanism of action in a single tablet that can address both underlying causes of hyperuricemia-overproduction and underexcretion of serum uric acid.
“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,” said Michael A. Becker, MD, professor emeritus of medicine, Department of Medicine, the University of Chicago. “This represents an important and needed new option in the treatment of hyperuricemia.”
“Gout is a serious and potentially progressive and debilitating inflammatory disease,” he added. “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 U.S. peak sales of $300 million.”
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, the company noted.
The efficacy and safety of lesinurad plus allopurinol were demonstrated in 2 pivotal Phase III clinical trials, CLEAR 1 and CLEAR 2, which supported the Zurampic® NDA. In clinical trials of adult patients with gout who did not achieve target sUA levels on allopurinol alone, lesinurad in combination with allopurinol nearly doubled the number of patients who achieved the sUA target of < 6 mg/dL at month 6, reduced the mean sUA level to < 6 mg/dL by month 1, and maintained that level through month 12.
The most common adverse reactions in clinical trials were headache, influenza, higher levels of blood creatinine, and heartburn. Duzallo has a boxed warning regarding the risk of acute renal failure.
Ironwood expects Duzallo to be commercially available early in the fourth quarter of 2017.