FDA questions AstraZeneca about safety of phase 3 gout drug
- AstraZeneca (AZ) has submitted a dossier for its investigational gout drug lesinurad to the FDA and is awaiting a panel recommendation. FDA staff have raised questions regarding the therapy's safety.
- Although AZ has had positive results in phase 3 in terms of efficacy, reports of serious side effects, including cardiovascular (CVD) and kidney-related issues, as well as higher death rates, have been a source of concern for FDA reviewers.
- Analysts have been positive about lesinurad's prospects, with revenue estimates for 2020 from Thomson Reuters Cortellis in the $350 million range.
The word "gout" often conjures up images of 19th century pot-bellied men with throbbing toes, groaning with pain. But it's a condition which affects roughly 8.3 million Americans and is categorized as a rheumatologic disease. Gout is a form of arthritis caused by a build-up of uric acid crystal deposits in the big toe, the kidneys, and other joints.
Despite positive data on lesinurad, the FDA may request additional safety data from AZ because of some of the worrisome adverse events reported in trials. Nonetheless, there is an unmet medical need associated with gout and AZ has a good shot at getting an approval in the not-too-distant future.