Approval of Duzallo is the next step in the development of Ironwood's gout franchise, a business the company predicts will generate $300 million a year in peak US sales.
The oral drug, which will be marketed as Duzallo, combines the current standard of care for treatment of hyperuricemia - allopurinol - with the more recently approved Zurampic.
The FDA has approved Ironwood Pharmaceuticals' Duzallo, a combination pill of lesinurad and allopurinol, for the treatment of hyperuricemia in patients with uncontrolled gout, according to a company press release.
"With Duzallo, almost 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 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", said Michael A. Becker, M.D., professor emeritus of medicine, Department of Medicine, The University of Chicago, Chicago, IL.
The efficacy and safety of the allopurinol and lesinurad combination were established in two clinical trials, CLEAR 1 (ClinicalTrials.gov Identifier: NCT01510158) and CLEAR 2 (NCT01493531) in which the number of patients who were able to achieve sUA target levels almost doubled. It is also available in a lesinurad 200 mg plus allopurinol 200 mg dosage.
McCourt added that Ironwood expects Duzallo to serve as a "critical driver" of its gout franchise, which is expected to exceed total annual USA peak sales of $300 million. The most common adverse reactions in clinical trials were headache, influenza, higher levels of blood creatinine (a measure of kidney function), and heartburn (acid reflux). Duzallo will be marketed with a boxed warning regarding the risk of acute renal failure, Ironwood said.