In late December, FDA approved AstraZeneca’s Zurampic (lesinurad) 200-mg tablets in combination with a xanthine oxidase inhibitor (XOI) for high levels of uric acid in the blood (hyperuricemia) associated with gout.
“A new approach to treating gout is long overdue, given there has been limited therapy innovation over the last 50 years,” said Lawrence Edwards, MD, chairman and CEO of the Gout and Uric Acid Education Society (GUAES), in an AstraZeneca statement. “Combination therapy with Zurampic is an important addition to the medicines available to physicians that will help more gout patients reach their serum uric acid treatment targets, which may ultimately relieve their suffering from this painful disease.”
Related:ACR: Lesinurad as a combo therapy with allopurinol may be effective in treating gout
"Controlling hyperuricemia is critical to the long-term treatment of gout," added Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA’s Center for Drug Evaluation and Research.
Here are the top 5 things to know about Zurampic:
- The drug works by inhibiting the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, Zurampic increases uric acid excretion and thereby lowers serum uric acid. In combination with the current standard of care, XOIs allopurinol or febuxostat, Zurampic provides a dual mechanism of action to increase excretion and decrease production of uric acid, enabling more patients with inadequately controlled gout to achieve target treatment goals.
- FDA's approval is based on data from three phase 3 studies, which represent the largest clinical trial data set of gout patients at more than 1,500 treated with combination urate lowering therapy. Participants treated with Zurampic in combination with a XOI experienced reduced serum uric acid levels compared to placebo.
- Gout is a serious and debilitating form of inflammatory arthritis caused by hyperuricemia (elevated sUA). It affects millions of people around the globe, many of whom do not reach recommended sUA treatment goals on XOIs, which decrease production of uric acid. For those inadequately controlled patients, the addition of a urate-lowering therapy to increase excretion of uric acid may help them achieve treatment goals.
- Zurampic is also under regulatory review in the European Union and other territories. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently adopted a positive opinion recommending the marketing authorization of Zurampic.
- This therapy has a boxed warning that provides important safety information for healthcare professionals, including the risk for acute kidney (renal) failure, which is more common when used without an XOI and with higher than approved doses of Zurampic. FDA also is requiring a postmarketing study to further evaluate the renal and cardiovascular safety of Zurampic.