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You are here: Home / Articles / FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

FDA Approves Duzallo for Hyperuricemia in Patients with Uncontrolled Gout

August 21, 2017 • By Reuters Staff

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(Reuters)—Ironwood Pharmaceuticals Inc. said on Monday the U.S. Food and Drug Administration (FDA) approved its oral drug to treat a condition associated with gout.

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The company’s once-daily drug, Duzallo (lesinurad and allopurinol), was approved to treat hyperuricemia in patients with gout, Ironwood said.

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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.

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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.

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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.

Filed Under: Conditions, Crystal Arthritis, Drug Updates Tagged With: Allopurinol, FDA, Food and Drug Administration, Gout, Ironwood Pharmaceuticals Inc., lesinurad

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