- Ironwood Pharmaceuticals, Inc. said on Monday that the Food and Drug Administration has approved its combination therapy for a condition associated with gout, expanding the biotech's portfolio of marketed products.
- The oral drug, which will be marketed as Duzallo, combines the current standard of care for treatment of hyperuricemia — allopurinol — with the more recently approved Zurampic. Hyperuricemia, or elevated serum uric acid levels in the blood, can lead to gout and painful flares.
- Duzallo will carry a black box warning for the risk of acute renal failure associated with the use of Zurampic. Ironwood said the drug would be commercially available early in the fourth quarter.
Approval of Duzallo is the next step in the development of Ironwood's gout franchise, a business the company predicts will generate $300 million a year in peak U.S. sales.
Last year, Ironwood picked up U.S. rights to Zurampic (lesinurad) from AstraZeneca plc in a deal that sent the British drugmaker $100 million upfront. Additional sales milestones could push the total deal value as high as $265 million if all thresholds are met.
Duzallo is designed to treat those patients whose serum uric acid levels are not adequately controlled with allopurinol or other xanthine oxidase inhibitos alone — a patient population Ironwood estimates numbers roughly two million in the U.S.
The drug will combine allopurinol with Zurampic in a fixed-dose combination administered as a single tablet once-daily.
Ironwood conducted a pharmacokinetic study, which demonstrated the bioequivalence of the combo with co-administration of separate lesinurad and allopurinol tablets. This study, together with the clinical program for Zurampic, supported Ironwood's New Drug Application for Duzallo.
In addition to Zurampic and now Duzallo, Ironwood shares in the commercialization of Alelrgan plc's constipation drug Linzess (linaclotide). The companies split net profits from Linzess equally in the U.S., while Allergan has an exclusive license to the drug in all countries outside of North America excepting China, Hong Kong, Macau and Japan.