Letter to the FDA Urging the Agency not to Approve the New Drug Application for Lesinurad
December 7, 2015
View as PDF.
February 22, 2016,
response letter from the FDA.
Public Citizen opposes Food and Drug Administration (FDA) approval of the new drug application for lesinurad for treatment of hyperuricemia associated with gout because the drug offers meager clinically meaningful benefits relative to placebo for gout patients with hyperuricemia and has serious risks, including definite significant kidney toxicity and possible cardiovascular toxicity. FDA approval — with reliance on warnings in the product labeling, a risk evaluation and mitigation strategy, and postmarket safety studies — would be a reckless approach and would not be in the interests of public health.