The U.S. Food and Drug Administration (FDA) has begun to ask questions about the safety of AstraZeneca’s drug, Zurampic (lesinurad).
According to Reuters, Zurampic, used in combination with febuxostat, is a treatment for Gout.
Originally developed by Ardea Biosciences, Zurampic was purchased by AstraZeneca for $1.26 billion in 2012. Sales of the drug are forecasted to reach $350 million by 2020, but it still is not considered to be a major contributor to AstraZeneca’s sales.
Staff reviewers of the FDA have begun to ask questions about the health risks of the drug. The questions stem from the higher death rates, cardiovascular issues, and kidney-related side effects that have been correlated with patients who took the medicine. Their findings were published in a preliminary review last Wednesday.
A panel of advisors will take into account the information from the review and provide a recommendation for the drug. This panel is independent of the FDA, and its advice will most likely be followed by the FDA.