Ironwood Pharma’s gout drug gets FDA’s approval

Ironwood Pharma’s gout drug gets FDA’s approval

The Food and Drug Administration (FDA) has approved Ironwood Pharmaceuticals oral drug to treat a condition characterized by too much uric acid in blood in patients with gout.

Duzallo is a fixed-dose oral combination of lesinurad and allopurinol that is used to treat hyperuricemia in gout patients for whom target serum uric acid levels haven’t been achieved with only allopurinol.

Dr. Michael A. Becker, a professor emeritus of medicine at the University of Chicago’s Department of Medicine, welcomed the FDA’s decision, saying it would provide a new option to help patients with gout.

Becker said in a statement, “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. This represents an important and needed new option in the treatment of hyperuricemia.”

However, Duzallo comes with a “black box” warning about the risk of acute renal failure. Such a warning is the federal health agency’s severest caution against serious side effects of a medicine.