Regulatory Affairs

Ironwood’s Duzallo gets FDA approval for gout-associated hyperuricemia

PBR Staff Writer Published 22 August 2017

Ironwood Pharmaceuticals’ Duzallo has been approved by the US Food and Drug Administration (FDA) for the treatment of hyperuricemia in patients with uncontrolled gout.

Duzallo is a combination of 200mg of lesinurad and 300mg of allopurinol and has been approved by the regulator as a once-daily oral therapy for treating the condition in gout patients who did not show target levels of serum uric acid (sUA) with a medically appropriate daily dose of allopurinol alone.

According to Ironwood, the fixed-dose lesinurad and allopurinol combination has a dual mechanism of action in a single tablet of Duzallo which can regulate both overproduction and underexcretion of serum uric acid, the two major causes of hyperuricemia.

Duzallo is also available in a 200mg lesinurad and 200mg allopurinol combination, stated the Massachusetts drug maker.

FDA’s approval of Duzallo was based on the findings of the clinical trial backing the Zurampic (lesinurad) new drug application (NDA). The regulator also took into account a pharmacokinetic study that assessed the bioequivalence of the lesinurad and allopurinol fixed-dose combination against the co-administration of lesinurad and allopurinol tablets taken separately.

Ironwood marketing and sales senior vice president and chief commercial officer Tom McCourt said: “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.

“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.”

Following its approval, Ironwood expects the hyperuricemia drug to be launched commercially in the fourth quarter of the year.

Image: DUZALLO (lesinurad and allopurinol). Photo: courtesy of Business Wire.