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Home Industry News Amgen receives EU approval for new Repatha dosing option

Amgen receives EU approval for new Repatha dosing option

23rd February 2017

Amgen has announced that its cholesterol therapy Repatha has been approved in Europe for use in a new dosing option.

The European Commission has adopted a decision to change Repatha's marketing authorisation to include a single-dose delivery option. The new automated mini-doser comes with a pre-filled cartridge providing 420 mg of Repatha in a single injection.

This makes Repatha the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor in Europe with the option of a single monthly injection, as well as being the first to offer a hands-free administration option.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "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."

Repatha was the first PCSK9 inhibitor to gain marketing authorisation in Europe as an every-two-week or monthly dosing regimen. It is used as an adjunct to diet for the treatment of high cholesterol, in combination with statins or other lipid-lowering therapies.

The drug has also been approved in combination with other lipid-lowering agents in patients with homozygous familial hypercholesterolaemia.

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