FDA Approves Duzallo, a New Combo Therapy for Gout

The US Food and Drug Administration has approved Ironwood Pharmaceuticals’ DUZALLO, a once-daily oral treatment for hyperuricemia associated with gout.

The drug is specifically approved for patients with gout who have not achieved target serum uric acid (sUA) levels with allopurinol alone, and is the first drug that combines the allopurinol — the current standard of treatment for hyperuricemia associated with gout –with lesinurad – the FDA’s most recently approved treatment.

The fixed-dose combination offers a dual mechanism of action within a single tablet that addresses overproduction and under excretion of serum uric acid — two underlying causes of hyperuricemia.

Ironwood expects DUZALLO to be available commercially in late fall or early winter 2017, according to a company statement.

“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, MD, professor emeritus of medicine, Department of Medicine, University of Chicago. “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 serum uric acid levels to goal despite taking allopurinol alone.”

The FDA approved DUZALLO based on evidence from the lesinurad (ZURAMPIC) new drug application (NDA), as well as a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared to the co-administration of separate lesinurad and allopurinol tablets.

The drug combination’s safety and efficacy were evaluated in patients with gout who failed to achieve target sUA levels on allopurinol alone in the CLEAR 1 and CLEAR 2 pivotal phase 3 clinical trials, which supported lesinurad’s NDA.

In combination with allopurinol, lesinurad nearly doubled the number of patients who achieved sUA target of <6mg/dL at month 6, reduced the mean sUA level to <6mg/dL by month 1 and maintained that level through month 12.

Common adverse reactions included headache, higher levels of blood creatinine, influenza, and heartburn. The drug contains a boxed warning for the risk of acute renal failure.