Amgen receives EU approval for new Repatha dosing option

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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