Amgen Receives Positive EU Committee Opinion on Dose Delivery For Cholesterol-Reducing Drug


Amgen said it received a positive opinion from a European drug committee for a new single-dose delivery option for Repatha.

Repatha is an antibody that blocks a protein which inhibits the body from eliminating “bad” cholesterol from the blood, Amgen noted.

If the European Commission reviews the positive opinion and decides to approve a marketing authorization extension for Repatha, Amgen said the drug would represent the first proprotein convertase subtilisin/kexin type 9 inhibitor in Europe with the option of a single monthly injection.

Amgen said Repatha became the first PCSK9 inhibitor to receive marketing authorization in Europe as an every-two-week or monthly dosing regimen in July 2015.

The company said the new single-dose delivery option will be available in Europe next year, depending on reimbursement requirements.