AstraZeneca nabs two big European nods for gout & heart meds
- 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).
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).
- Pharma Times EU nod for AZ gout, heart drugs