Amgen (NSDQ:AMGN) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for its Repatha single monthly injection device. The device is already cleared in Europe for dosing every 2 weeks.
The hands-free device, with prefilled cartridges, delivers 420 milligrams of Repatha (evolocumab) in a single injection. Repatha, a human monoclonal antibody, inhibits a protein which is responsible for blocking the body’s system that naturally eliminates low-density lipoprotein cholesterol.
“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,” executive VP of research & development Dr. Sean Harper said in prepared remarks. “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.”
If the device is approved by the European Commission, it would be the 1st inhibitor of its kind in Europe with a single monthly injection option. The FDA approved the single monthly injection device in July this year.
Repatha is approved in Europe as a complementary therapy to diet changes for patients with high cholesterol, in combination with statins. The device is also approved with patients with homozygous familial hypercholesterolemia.