FDA approves Ironwood Pharma's gout drug

Barsaba Taglieri
Agosto 22, 2017

Duzallo, manufactured by Ironwood Pharmaceuticals, is a once-daily combination of lesinurad (Zurampic, AstraZeneca) and allopurinol created to achieve target serum uric acid (sUA) levels in patients who can not do so with allopurinol alone.

"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".

Duzallo will be available in dosages that combine 200 mg of lesinurad with 300 mg of allopurinol, as well as 200 mg of lesinurad plus 200 mg of allopurinol. "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", Becker said.

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. "We believe DUZALLO will be the critical driver behind Ironwood's gout franchise, which is expected to exceed total annual USA peak sales of $300 million".

Ironwood conducted a pharmacokinetic study, which demonstrated the bioequivalence of the combo with co-administration of separate lesinurad and allopurinol tablets.

Ironwood Pharmaceuticals announces FDA approval of Duzallo (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout [news release].

The most common adverse events included headache, influenza, higher levels of blood creatinine, and heartburn. Duzallo is also contraindicated in patients with tumor lysis syndrome, Lesch-Nyhan syndrome, or prior known hypersensitivity to allopurinol.

Duzallo will carry a black box warning for the risk of acute renal failure associated with the use of Zurampic.

The DUZALLO NDA was submitted by Ardea Biosciences, Inc. on behalf of Ironwood.

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