AstraZeneca’s application for lesinurad, an unevenly successful gout treatment, has been accepted by the European Medicines Agency (EMA).
AstraZeneca acquired lesinurad as part of the $1.3 billion purchase of Ardea Biosciences in 2013. The EMA’s Committee for Medicinal Products for Human Use now will decide whether to grant approval to lesinurad to supplement the usual gout therapy. Lesinurad is a selective uric acid reabsorption inhibitor that blocks the URAT1 transporter, treating gout by normalizing acid excretion and reducing serum levels.
While lesinurad was able to meet its benchmarks in three Phase III clinical trials by cutting the uric acid that can cause gout flare-ups, it did not surpass generic allopurinol’s success rate in actually reducing the number of reported gout exacerbations, a secondary goal in two of its studies.
If the drug wins EMA and U.S. Food and Drug Administration (FDA) approval, AstraZeneca may still find it hard to convince payers to buy a new therapy without evidence of improved performance over the 50-year-old generic allopurinol and Takeda and Ipsen’s febuxostat, in use since 2009.