Health and Healthcare

AstraZeneca Gets European Approval for Heart Attack, Gout Treatments

Trey Thoelcke

Published: February 19, 2016 7:10 am

Last Updated: January 13, 2020 1:00 pm

Shares of pharmaceutical giant AstraZeneca PLC (NYSE: AZN) ticked down in Friday’s premarket trading in New York after the company announced that the European Commission (EC) had granted marketing authorization for two of its treatments: Zurampic for gout and Brilique for heart attack patients.

Both treatments were approved by the U.S. Food and Drug Administration (FDA) last year.

The EC has granted marketing authorization for Zurampic (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of an XOI alone. As part of the approval, AstraZeneca will conduct a Non-Interventional Post-Authorisation Safety Study (PASS) to investigate the cardiovascular safety profile (mainly in patients with history of cardiovascular disorder) exposed to Zurampic.

Brilique (ticagrelor) was approved at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event. Treatment may be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti-platelet therapy.

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