EU accepts Astrazeneca's application for marketing gout treatment
The European medicine regulator has approved AstraZeneca's application to market its lesinurad 200mg tablets for gout.
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Lesinurad helps increase uric acid excretion from the body to relieve gout.
The European Medicines Agency accepted the FTSE 100 drug developer's marketing authorisation application (MAA) after it completed 12-month pivotal Phase III combination therapy studies.
Lesinurad was the clinically most advanced product candidate of Ardea Biosciences, which Astrazeneca acquired for $1bn in 2012.
The drug is a selective uric acid reabsorption inhibitor (SURI) developed for the chronic treatment of hyperuricaemia in combination with xanthine oxidase (XO) inhibitors allopurinol or febuxostat in gout patients when additional therapy is warranted.