FDA Approves Duzallo for Hyperuricemia in Uncontrolled Gout

In trial, nearly twice as many hit uric acid targets with allopurinol/lesinurad combination

The FDA has approved Duzallo (allopurinol/lesinurad, Ironwood Pharmaceuticals) as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. The drug is not recommended for the treatment of 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 recently FDA-approved treatment for this condition, lesinurad (Zurampic, Ironwood Pharmaceuticals). 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.

Gout is a highly symptomatic and painful form of inflammatory arthritis caused by hyperuricemia, or elevated serum uric acid levels in the blood, which can lead to painful flares and serious potential long-term health consequences.

The FDA approval of Duzallo was based on the clinical program supporting the lesinurad new drug application (NDA) and a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination of lesinurad and allopurinol compared to coadministration of separate lesinurad and allopurinol tablets. The efficacy and safety of lesinurad plus allopurinol were demonstrated in two phase 3 clinical trials, which supported the lesinurad NDA. In clinical trials of adults with gout who failed to achieve target serum uric acid levels on allopurinol alone, lesinurad in combination with allopurinol nearly doubled the number of patients who achieved the serum uric acid target of less than 6 mg/dL at month 6, reduced the mean serum uric acid level to less than 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 acid reflux. Duzallo has a boxed warning regarding the risk of acute renal failure, which is associated with lesinurad.

In a press release, Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood, projected that the drug will be a critical driver of the company’s gout franchise, which is expected to exceed total annual U.S. peak sales of $300 million. Ironwood expects the drug to be commercially available early in the fourth quarter of 2017.

Source: Ironwood Pharmaceuticals; August 21, 2017.