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.
Ironwood Pharmaceuticals will market Duzallo (lesinurad and allopurinol), which is indicated as a once-daily oral treatment for hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with a medically appropriate daily dose of allopurinol alone. The combination ensures that both underlying causes of hyperuricemia - overproduction and underexcretion of uric acid - are treated.
Ironwood expects its portfolio of gout drugs to generate more than $300 million in annual US peak sales, said Tom McCourt, the company's chief commercial officer.
"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".
"With Duzallo, almost twice as many patients with uncontrolled gout may be able to achieve target sUAlevels 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", Tom McCourt, Ironwood's svp of marketing and sales and chief commercial officer, said in a statement.
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Duzallo should not be prescribed to patients with estimated creatinine clearance of 30 mL/min, end-stage renal disease, and patients on dialysis.
The warning is a result of the risk of acute renal failure associated with lesinurad, which was also approved with a boxed warning, Ironwood said in an e-mailed statement.
The most common adverse reactions identified were skin rash, nausea, and diarrhea. "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".
The DUZALLO NDA was submitted by Ardea Biosciences, Inc. on behalf of Ironwood.