New Repatha dose delivery option receives positive CHMP opinion

The new automated mini doser with prefilled cartridge is a hands-free device designed to provide 420 mg of Repatha in a single injection per administration.

If approved by the European Commission (EC), Repatha would be the first PCSK9 inhibitor in Europe with the option of a single monthly injection. Repatha was the first PCSK9 inhibitor to gain marketing authorization in Europe as an every-two-week or monthly dosing regimen on 17 July 2015. Repatha AMD will be available in Europe during 2017 depending on reimbursement requirements.

"We are pleased to advance our new dosing administration option and look forward to continuing our work with regulators to bring it to patients in Europe," said Sean E. Harper, executive vice president of Research and Development at Amgen. "The approval of this delivery system will provide an alternative for patients who need the additional LDL lowering that Repatha can provide and are seeking less frequent administration."

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 maximum 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. Top-line results from the approximately 27,500-patient event-driven FOURIER study are anticipated in first quarter of 2017.

The CHMP positive opinion will now be reviewed by the EC and if granted, the marketing authorization will be extended to include the 420 mg single injection in the 28 member countries of the European Union (EU), as well as Iceland, Lichtenstein and Norway.

CHMP's positive opinion follows the FDA's approval of the single 420 mg monthly injection option on 11 July 2016, as the Repatha Pushtronex system (on-body infusor with prefilled cartridge).

More than 60% of high-risk patients in Europe are still unable to adequately lower their LDL-C levels with statins or other currently approved lipid-lowering agents. Among very high-risk patients, the percentage is increased to more than 80%. The health care cost of cardiovascular disease (CVD) in the EU is approximately €106 billion per year.