FDA Approves New Option for Hyperuricemia Associated with Gout
The US Food and Drug Administration recently approved Duzallo for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with allopurinol alone.
Duzallo is the first drug to combine allopurinol, the current standard of care for hyperuricemia associated with gout, and lesinurad, the most recent FDA-approved treatment for this condition. The fix-dose combination addresses the overproduction and underexcretion of serum uric acid, which are both underlying causes of hyperuricemia. The single tablet is administered orally once a day, and is available with combined doses of 200 mg of lesinurad and 300 mg of allopurinol, or combined doses of 200 mg of lesinurad and 200 mg of allopurinol.
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Approval of Duzallo was based on clinical trials that evaluated the safety and efficacy of the combined therapy among adult patients with gout who failed to achieve target sUA levels on allopurinol alone. Duzallo was found to nearly double the number of patients who achieved target sUA at 6 months. In addition, the mean sUA in patients treated with Duzallo was reduced to less than 6 mg/dL by 1 month, and this level was maintained through 12 months.
Common adverse reactions associated with Duzallo in clinical trials included headache, influenza, higher levels of blood creatinine, and heart burn. In addition, Duzallo has a boxed warning for the risk of acute renal failure associated with lesinurad.
Patients with asymptomatic hyperuricemia are not recommended to receive Duzallo.
—Melissa Weiss
Reference:
Ironwood Pharmaceuticals announces FDA approval of DUZALLO® (lesinurad and allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout [press release]. Cambridge, MA: Ironwood Pharmaceuticals; August 21, 2017. http://news.ironwoodpharma.com/phoenix.zhtml?c=228069&p=irol-newsArticle&ID=2294774. Accessed August 21, 2017.