AstraZeneca announced Friday that its gout treatment drug Lesinurad has been recommended for approval by the U.S. Food and Drug Administration's Arthritis Advisory Committee.
Voting 10 to four, the advisory recommended 200 mg Lesinurad tablets for treating hyperuricemia associated with gout, to be used alongside a xanthine oxidase inhibitor. To arrive at their decision, committee members reviewed the largest phase III data set from gout patients treated with a combination of urate lowering therapies. The FDA is not obligated to follow the recommendation but it does take into consideration the Advisory Committee's findings when reviewing drugs for approval.
If approved by the FDA, Lesinurad will become the country's first selective uric reabsorption inhibitor (SURI), which works by inhibiting URAT1, a urate transporter responsible for most of uric acid reabsorption that occurs within the kidneys. The drug will also inhibit OAT4, a uric acid transporter that affects hyperuricemia induced by diuretics, but not OAT1 and OAT3, kidney drug transporters involved in drug-drug interactions.
"We look forward to the outcome of the FDA's review and the opportunity to provide a new treatment option that ... addresses both the under-excretion and over-production of uric acid," said Sean Bohen, Chief Medical Officer and Global Medicines Development Executive Vice President for AstraZeneca.
A chronic, progressive and debilitating form of inflammatory arthritis, gout currently affects more than 8.3 million people in the U.S. The condition's underlying cause is hyperuricemia, where an elevated level of serum uric acid that causes crystals to be deposited around the body but mainly in the joints. This results in recurring arthritic inflammations that may progress into chronic arthritis and the formation of tophus, or visible urate crystal deposits.
The American College of Rheumatology and the European League Against Rheumatism has recommended levels of serum uric acid. However, clinical trials showed that these levels were met by less than half of patients who were administered with popular gout drug Allopurinol. This means that about 2 million patients undergoing gout treatment are not getting the results they are looking for.
Almost always, gout symptoms occur suddenly without warning and typically at night. Symptoms include intense joint pain, lingering discomfort, redness, inflammation and limited range of motion. Immediate medical attention is advised when these symptoms are accompanied by a fever as that may be indicative of an infection.
Photo: Gulan Bollsay | Flickr
