Aug 21 (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.
The company’s once-daily drug, Duzallo, was approved to treat hyperuricemia — a condition characterized by too much uric acid in blood — in patients with gout, Ironwood said.
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. Such a warning is the FDA’s severest caution against serious side effects.
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.
Ironwood last year bought the U.S. marketing rights for lesinurad from AstraZeneca Plc for an upfront payment of $100 million.
Gout is an intensely painful condition involving tender joints and redness that is caused by a build-up of uric acid in joints. It affects about 4 percent 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, Massachusetts-based company were up 6.9 percent at $15.50 in premarket trading. (Reporting by Tamara Mathias in Bengaluru; Editing by Sai Sachin Ravikumar)