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

Drug Delivery Business

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

Teva wins EU nod for Ajovy migraine prophylactic

April 2, 2019 By Fink Densford

Teva Pharmaceutical logo - updated

Teva (NYSE:TEVA) said yesterday that it won EC Marketing Authorization in the European Union for its Ajovy pre-filled syringe injection meant to serve as a prophylaxis for migraines in adults who experience at least four migraine days per month.

The Israel-based company said that Ajovy is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide ligand and blocks its binding to the receptor.

Teva touted that Ajovy is the first and only anti-CGRP drug approved in the European Union and the U.S. intended for the prevention of migraine that offers both quarterly and monthly dosing options.

“Migraine is a debilitating neurological disease which can have a substantial impact on quality of life. The disease is most common between the ages of 25 and 55 meaning that it strikes during the most productive years, disrupting patients’ personal and professional lives. The approval of fremanezumab in the EU will provide European physicians with an important new treatment option offering patients greater flexibility through monthly and quarterly dosing options and, most importantly, a significant reduction in the number of migraine days,” Messoud Ashina of the University of Copenhagen said in a prepared statement.

Data supporting the clearance came from two pivotal Phase III clinical trials that indicated that patients treated with Ajovy had significantly greater reduction in migraine days compared to placebo. Adverse drug reactions were mostly mild to moderate, short-lasting skin reactions around the injection area, including pain, hardening, redness, itching and rash at the injection site.

Teva said that Ajovy won FDA approval last September and that it has also filed for regulatory clearance with other global regulatory bodies.

“Migraine can have a significant impact on the day-to-day life of patients with some experiencing 15 headache days per month. It is our hope that Ajovy will provide patients and European healthcare professionals with a preventive treatment which offers patients more migraine free days as well as greater flexibility in managing this unpredictable disease. The approval of fremanezumab is also an important step in our focus on biopharmaceuticals, the next generation of innovative medicines, coupled with our ongoing commitment to developing treatments for disorders of the central nervous system,” Teva European commercial exec VP Richard Daniell said in a press release.

Last month, Teva said that it launched a generic version of Pfizer‘s (NYSE:PFE) Flector diclofenac epolamine patch.

Filed Under: Featured, Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: Teva

IN CASE YOU MISSED IT

  • MedAlliance wins second FDA IDE nod for drug-coated balloon
  • Wells Fargo downgrades Tandem amid rise of automated insulin delivery competition
  • FDA approves first targeted infusion therapy for HER2-low breast cancer
  • Abbott, WeightWatchers partner on diabetes care
  • Insulet up on Q2 sales beat, raised full-year guidance

Primary Sidebar

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.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

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
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · 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.

Advertise | Privacy Policy | RSS