Repatha (evolocumab) receives European Commission approval for new 420 mg single-dose delivery option.
Amgen announced that the European Commission (EC) has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. 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.
Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in Europe with the option of a single monthly injection. Repatha is a human monoclonal antibody that blocks a protein called PCSK9, which inhibits the body’s natural system for eliminating “bad” cholesterol (low-density lipoprotein cholesterol or LDL-C) from the blood.1
“Amgen is committed to advancing care and improving the lives of patients with cardiovascular disease,” said Sean E. Harper, M.D., executive vice president of research and development at Amgen. “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.”
Approval from the EC grants a change to the centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union (EU). Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the decision of the EC. The Repatha AMD will be available in Europe this year depending on reimbursement requirements.
In 2015, Repatha was the first PCSK9 inhibitor to gain marketing authorization in Europe as an every-two-week or monthly dosing regimen. In Europe, Repatha is approved as an adjunct to diet for the treatment of high cholesterol in combination with statins or other lipid-lowering therapies in patients unable to control their LDL-C with maximally tolerated statin doses, or alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated.
Repatha is also approved in combination with other lipid-lowering agents in patients with homozygous familial hypercholesterolemia (age 12 and over). The effect of Repatha on cardiovascular morbidity and mortality has not yet been determined.
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).
1 Repatha European Commission Summary of Product Characteristics.
(Source: PR Newswire)