AstraZeneca has bagged a green light for its gout therapy Zurampic in Europe, while regulators also approved a new indication for the firm’s bloodthinner Brilique.
Hot on the heels of its US clearance, Zurampic (lesinurad) has now also been approved for use in the European Union as a treatment option for adults with gout, a serious and debilitating form of inflammatory arthritis caused by elevated levels of serum uric acid (hyperuricaemia).
The decision allows doctors to prescribe the drug alongside the current standard of care - xanthine oxidase inhibitors (XOI) allopurinol or febuxostat - when patients have not achieved target serum uric acid levels despite treatment with either XOI alone.
In combination with XOIs, Zurampic provides a dual mechanism of action to increase excretion and decrease production of uric acid, enabling more patients with inadequately controlled gout to achieve target treatment goals, AZ said.
As part of the approval the firm will carry out a Non-Interventional Post-Authorisation Safety Study (PASS) to assess the drug’s cardiovascular safety profile, mainly in patients with history of cardiovascular disorder, as well as an EU renal study.
Brilique for longer-term heart attack risk
Meanwhile, Brilique (ticagrelor) has been approved at a new 60mg dose for treating patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.
“A growing body of evidence continues to show that the risk of experiencing a subsequent cardiovascular event continues beyond the first year after a patient has a heart attack,” said AZ’ Sean Bohen. “We are committed to finding new treatment solutions for these patients who remain at risk, and today’s approval is an important step forward in meeting this need.”
Brilique is an oral antiplatelet treatment that works by inhibiting platelet activation. A 90mg version is already approved in the EU for the prevention of atherothrombotic events in adults with acute coronary syndrome (ACS).
With this additional clearance, treatment with the 60mg dose may now be started as continuation therapy after an initial one-year treatment with Brilique 90mg and aspirin or other dual anti platelet therapy.