Dive Brief:
- The European Medicines Agency (EMA) has approved AstraZeneca's Zurampic for treatment of gout, in addition to its anticoagulant Brilique.
- Zurampic (lesurinad) is a selective uric acid reabsorption inhibitor, which is designed to normalize acid excretion and reduce serum levels.
- Brilique (ticagrelor) is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndromes (unstable angina, non-ST-elevation myocardial infarction or ST-elevation myocardial infarction), including patients managed medically, and those who are managed with percutaneous coronary intervention (PCI) or coronary artery by-pass grafting (CABG). It is intended to be used in combination with acetylsalicylic acid (ASA).
Dive Insight:
Based on the approval, Zurampic is intended to be used in combination with the current standard-of-care for gout—xanthine oxidase inhibitors.
The approval also comes with a post-marketing agreement in which AZ will conduct a Non-Interventional Post-Authorisation Safety Study (PASS) to assess the drug’s cardiovascular safety profile. The study will focus mainly on patients with a history of cardiovascular (CVD) events. There will also be an EU renal study as part of the overall post-marketing program.
The approval for Brilique (60 mg) is for secondary prevention of CVD events in high-risk patients who have already experienced a CVD event. The higher dose, 90 mg, is intended for use in patients with acute coronary syndrome (ACS).