• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Amgen wins recommendation for single injection Repatha device

December 19, 2016 By Sarah Faulkner

Amgen wins recommendation for single injection Repatha deviceAmgen (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.

Filed Under: Drug-Device Combinations, Featured, Regulatory/Compliance Tagged With: Amgen

IN CASE YOU MISSED IT

  • Insulet hires new chief HR officer from J&J
  • Breakthrough T1D, Mattel debut Barbie doll with type 1 diabetes
  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Diabeloop launches insulin delivery algorithm in Germany
  • GlucoModicum has positive data for needle-free CGM

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS