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Duzallo combines the standard-of-care treatment, allopurinol, with Ironwood’s lesinurad to treat inefficient excretion and overproduction of uric acid in gout patients.
Duzallo’s label comes with a black box warning regarding the risk of acute renal failure, the company said.
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 emailed statement.
Last year, Ironwood bought the U.S. marketing rights for lesinurad from AstraZeneca Plc. for an upfront payment of $100 million.
Gout affects about 4% of Americans, according to the U.S. Centers for Disease Control and Prevention.
Ironwood expects its portfolio of gout drugs to generate more than $300 million in annual U.S. peak sales, said Tom McCourt, the company’s chief commercial officer. Shares of the Cambridge, Ma.-based company were up 6.9% at $15.50 in premarket trading.