Amgen gets more options for using Repatha, EU approves single-dosing

Amgen on Tuesday got clearance from the European Commission (EC) for a new single-dose delivery option for its Repatha cardiovascular drug.

As stated by Amgen in a Tuesday press release, the European Commission has changed the Repatha (evolocumab) marketing authorization. The new option enables the automated mini-doser (AMD) with a pre-filled cartridge to provide 420 mg of Repatha in a single injection.

Amgen’s Repatha is the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in Europe with the option of a single monthly injection, the company notes.

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.”

EC’s approval brings new dosing of Repatha to the 28 members of the European Union (EU).

Amgen said that 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 should be available in Europe this year.

In addition, 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).