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.
Elena Ruiz de la Torre, Executive Director, European Migraine & Headache Alliance (EMHA) said: “Migraine is not just a headache, it is an unpredictable neurological disease which can frequently go undiagnosed and undertreated. After decades of migraine patients feeling left behind, we are delighted to see the progression of preventive treatments which offer patients new hope in managing their condition. The availability of a new treatment, which is specifically designed for the prevention of migraine, is another positive step forward for the migraine community and we welcome the fact that Europe’s more than 50 million patients will now have greater choice over their treatment options and more days uninterrupted by migraine."
AJOVY was evaluated in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylactic treatment for migraine in adults. In these trials, patients treated with fremanezumab had a significantly greater reduction in migraine days compared to placebo. Adverse drug reactions (ADRs) observed with fremanezumab were mostly mild to moderate, short-lasting skin reactions around the injection area: pain, hardening, redness, itching and rash at the injection site.
Messoud Ashina, Professor of Neurology in the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark, stated: “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.”
Richard Daniell, Executive Vice President, European Commercial at Teva said: “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 (CNS).”
The EC decision is applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein after transposition into legally binding acts in these countries. AJOVY received U.S. FDA approval for the preventive treatment of migraine in adults on 14 September 2018. Additional regulatory filings are underway with other health authorities worldwide.
About AJOVY ®
AJOVY (fremanezumab) is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. AJOVY is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY can be administered in by a healthcare professional or at home by a patient or caregiver if instructed by a healthcare professional in subcutaneous self-injection technique.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 43,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Teva Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding EU approval of AJOVY, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
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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
Kevin C. Mannix
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