The European Commission has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option.
According to Amgen, Repatha can be delivered via a new automated mini-doser (AMD) with a pre-filled cartridge. The FDA had previously approved the single 420 mg monthly injection option on July 11, 2016, as the Pushtronex system for use with Repatha.
Repatha is the first proprotein convertrase subtilisin/kexin type 9 (PCSK9) inhibitor with the option of a single monthly injection in Europe. The approval means the drug will have centralized marketing authorization in 28 countries in the European Union.
"Amgen is committed to advancing care and improving the lives of patients with cardiovascular disease," Dr. Sean Harper, executive vice president of Research and Development at Amgen, said in a statement. "We are proud to bring this dosing alternative to patients in Europe, providing another option for them to incorporate Repatha into their cardiovascular care, with less frequent and hands-free administration."
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