Amgen (NSDQ:AMGN) said today that the European Commission granted a change to the marketing authorization of its Repatha device, approving a single-dose delivery option. The pre-filled cartridge mini-doser is a hands-free device that is designed to provide 420 mg of Repatha (evolocumab) in a single injection for patients with cardiovascular disease.
The company touted its PCSK9 inhibitor as the 1st of its kind to offer a single monthly injection option in Europe.
The inhibitor is a human monoclonal antibody that blocks a protein which is responsible for blocking the body’s system that naturally eliminates low-density lipoprotein cholesterol.
“Amgen is committed to advancing care and improving the lives of patients with cardiovascular disease,” executive VP of R&D Dr. Sean Harper said in prepared remarks. “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.”
The Repatha mini-doser will be available in Europe this year, contingent upon reimbursement requirements, according to Amgen.
Repatha was the 1st PCSK9 inhibitor to win marketing authorization in Europe as an every-2-week or monthly dosing practice, the company reported. Repatha is approved as an add-on therapy to diet for patients with high cholesterol, in combination with statins or other lipid-lowering agents.
In July last year, the FDA approved the single-dose delivery option for Repatha using the on-body injection system Pushtronex.
Earlier this month, Amgen shares rose after the pharmaceutical company met expectations on Wall Street with its 4th quarter results and touted data from a trial for Repatha.
The Thousand Oaks, Calif.-based company posted profits of $1.94 billion, or $2.59 per share, on sales of $5.97 billion for the 3 months ended Dec. 31, for bottom-line growth of 8% on sales growth of 8% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were $2.89, ahead of consensus on The Street, where analysts were looking for sales of $5.74 billion.