EU approves change to authorisation for Repatha (evolocumab) to approve single-dose delivery option in dyslipidaemia treatment- Amgen

Amgen announced that the European Commission (EC) has adopted a decision to change the Repatha (evolocumab) marketing authorisation, approving a new single-dose delivery option in dyslipidaemia treatment. The new automated mini-doser (AMD) with a pre-filled cartridge is a hands-free device that provides 420 mg of Repatha in a single injection per administration. The U.S. Food and Drug Administration approved the single 420 mg monthly injection option on July 11, 2016, as the Pushtronex system for use with Repatha (on-body infusor with prefilled cartridge).

The Repatha cardiovascular outcomes trial (FOURIER) is designed to evaluate whether treatment with Repatha in combination with statin therapy, compared to placebo plus statin therapy, reduces the risk of cardiovascular events in patients with high cholesterol and clinically evident cardiovascular disease, and completed patient enrollment in June 2015. Top-line results from the approximately 27,500-patient event-driven Repatha cardiovascular outcomes study were announced by Amgen in February 2017. Detailed results from the Repatha cardiovascular outcomes study will be presented at the American College of Cardiology 66th Annual Scientific Session.