• 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

With groundbreaking approval, Amgen launches new class of medicine for migraine patients

May 18, 2018 By Sarah Faulkner

AmgenAmgen (NSDQ:AMGN) won FDA approval this week for its once-monthly Aimovig injection designed to prevent the onset of migraines in adults.

The drug is the first of its kind – a molecule that blocks the receptor for a protein that is linked to migraine pain, the calcitronin gene-related peptide. Other major pharmaceutical companies like Eli Lilly (NYSE:LLY) and Teva Pharmaceuticals (NYSE:TEVA) are working on their own CGRP product, but Amgen’s is the first to hit the market.

Migraines aren’t just headaches – the condition is marked by focused, throbbing pain that can render people sensitive to light and sound. It affects more than 10% of people worldwide, according to the FDA, and nearly 38 million in the U.S. alone.

Amgen’s subcutaneous injection is delivered using the company’s SureClick auto-injector and priced at $6,900 per year. The pricetag fell below analysts estimates. The Institute for Clinical & Economic Review pegged the product’s annual price at $8,500.

In a 12-week Phase III trial, Amgen enrolled 246 people with episodic migraine who previously failed treatment. The study met its primary endpoint, which was the proportion of patients with at least 50% reduction of monthly migraine days after four weeks of treatment.

Aimovig is slated to be available for patients within one week.

“The FDA approval of Aimovig represents a long-awaited and important therapeutic development for patients and their physicians who are in need of additional treatment options for the prevention of migraine,” Dr. Sean Harper, EVP of R&D at Amgen, said in prepared remarks.

A “very promising development”

For patients that are seeking preventive treatment for migraines, there are other options on the market – but they’re all drugs that were never specifically developed for that indication. For instance, some patients use a blood pressure drug that incidentally helps to prevent migraines.

But these drugs are not very effective, according to neurologist Dr. Egilius Spierings of Tufts University, and they have an array of side effects like exhaustion and weight gain.

Spierings has practiced for more than four decades and he described Amgen’s latest regulatory win as a “very promising development” for patients.

He has treated close to 250 patients across the four CGRP-antibodies in development, he told Drug Delivery Business News, and has been amazed by the medicine’s tolerability.

“I have never worked with a class of medicines this well-tolerated and this effective,” Spierings said.

CGRP-antibodies have been “life-changing” for many of Spierings’ patients. He has been involved in CGRP trials since 2012 and in just six years, the first CGRP-antibody is ready for prime-time.

“I believe this is going to change the face of migraine management all-together,” Spierings said.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Amgen, Eli Lilly & Co., Teva Pharmaceuticals

IN CASE YOU MISSED IT

  • Dexcom updates CGM receiver recall that led to serious adverse events
  • Abbott reports momentum with Libre CGM business as new dual sensor will ‘accelerate’ growth
  • Johnson & Johnson wins FDA priority review for drug delivery system
  • Glucose monitoring company LifeScan files chapter 11 to reduce debt
  • Medtronic enrolls first patient in study for Onyx liquid embolic system

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