Ironwood Pharmaceuticals Announces FDA Approval for Duzallo

By | August 23, 2017

Cambridge-based Ironwood Pharmaceuticals has announced Duzallo was approved by the FDA as a treatment for hyperuricemia, or elevated serum uric acid levels (sUA) in the blood, associated with gout. Duzallo is the first drug that combines the current standard of care for the treatment of hyperuricemia associated with gout, the xanthine oxidase inhibitor (XOI) allopurinol, with the most recent FDA-approved treatment for this condition, lesinurad.

Allopurinol reduces the production of uric acid (UA); lesinurad increases renal excretion of UA by selectively inhibiting the action of URAT1, the UA transporter responsible for the majority of renal UA reabsorption. The dual-mechanism combination of Duzallo can address both inefficient excretion and overproduction of UA, thereby lowering sUA levels.

Tom McCourt, senior vice president of marketing and sales and chief commercial officer at Ironwood, said the company believes “…Duzallo will be the critical driver behind Ironwood’s gout franchise, which is expected to exceed total annual U.S. peak sales of $300 million.”

Gout is a painful form of inflammatory arthritis caused by hyperuricemia and the most common form of inflammatory arthritis in adults. Some patients can lower sUA levels sufficiently by using a XOI such as allopurinol. However, an estimated two million patients currently treated with an XOI in the U.S. suffer from uncontrolled gout.

The Duzallo NDA was submitted by Ardea Biosciences, Inc. on behalf of Ironwood. (Source: Ironwood Pharmaceuticals Website, August 21, 2017)