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Teva’s AJOVY® Receives EU Marketing Authorisation


Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults

  • In clinical trials, many patients on AJOVY experienced significant reductions of at least 50% in the number of monthly migraine days with reduction observed as early as week one 1,2
  • Migraine is the most prevalent neurological disorder affecting more than 50 million people in Europe and 1 billion worldwide 3,4

JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the European Commission (EC) has granted the Marketing Authorization for AJOVY(fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY is a humanized monoclonal antibody (mAb) that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. AJOVY is the first and only anti-CGRP drug approved in the European Union (EU) and the United States (US) that is designed for the prevention of migraine that offers both quarterly and monthly dosing options for the phrophylatic treatment of migraine.

References

1 Dodick DW et al. JAMA 2018; 319(19): 1999–2008

2 Silberstein SD et al. N Engl J Med 2017; 377(22): 2113–2122

3 Headache. EAN. Available at: https://www.ean.org/index.php?id=2796 Accessed: 22 February 2019

4 Migraine Research Foundation, Migraine Facts. Available at: http://migraineresearchfoundation.org/about-migraine/migraine-facts/ Accessed: 22 February 2019

About Teva

Teva is among the top 15 global pharmaceutical companies globally, delivering high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 60 markets every day. Teva produces a leading innovative treatment for multiple sclerosis and has late-stage development programs for a range of disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions.

With its European headquarters in Amsterdam, the Netherlands, Teva is also the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a broad range of products in nearly every therapeutic area. Teva draws on its specialty and generics capabilities to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2017 were $22.4 billion. For more information, visit http://www.tevaeurope.com/news.

PR Contacts:

Fiona Cohen 

Amsterdam

+31 620 08 25 45