Last week, the Food and Drug Administration (FDA) has approved lesinurad, which will be marketed under the brand name Zurampic, as an add-on medication for patients with gout.
According to an article in MedPage Today, three phase 3 trials supported the FDA’s approval as they showed that lesinurad significantly increased the number of patients reaching biomarker targets and lowered serum uric acid to target levels in six months.
During the FDA’s advisory committee meeting on the medication in October, a panel voted 10-4 to recommend approval, but this was despite the panel being split on the drug’s safety profile at higher doses. The FDA approved Zurampic at lower tested doses of 200 mg.
At the October advisory committee meeting, CreakyJoints patient advocate David Belton of West Virginia spoke candidly about his 20-year struggle with the debilitating condition and how his participation in a clinical trial examining lesinurad helped him find a treatment that improves his flare ups significantly. Read about his active role in the committee meeting here.
To read the full MedPage Today article on the FDA approval of lesinurad, click here.