TEL AVIV, Israel--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) presented a wide range of important new data on AJOVY® (fremanezumab) and the societal and economic impact of migraine in Europe at the 6th Congress of the European Academy of Neurology (EAN). This year’s EAN congress was a virtual meeting due to the global coronavirus pandemic.
The fremanezumab data included pooled analyses of the AJOVY Phase 3 clinical trials (FOCUS, HALO-episodic migraine (EM) and HALO-chronic migraine (CM)) which focused on the safety, efficacy and improved quality-of-life for patients experiencing difficult-to-treat migraine. Post-hoc analyses were also evaluated in patients who may experience challenges when managing their migraine due to comorbidities.
Migraine creates a significant disease and economic burden. With more than one billion people impacted globallyi, migraine is the second leading global cause of years lived with disabilityii and annual costs of the disease in the U.S. and EU are $200 billion.iii,iv
“Migraine imposes physical, emotional and societal burdens worldwide and yet available treatment options are often unsatisfactory for many patients,” said Joshua M. Cohen, MD, MPH, FAHS, Senior Director, Global Medical Affairs – Therapeutic Area Lead Migraine & Headache, Teva. “As a leader in neurology and migraine treatment, Teva’s goal is to continue evaluating the impact of AJOVY across various patient populations to ensure that reliable and relevant information is available to healthcare professionals when considering treatment options.”
Pooled Analysis Shows Impact of AJOVY in Patients with Migraine
Pooled analyses of the Phase 3 FOCUS, HALO-EM and HALO-CM clinical trials in patients 60 years of age or older with EM or CM, examined treatment with fremanezumab versus placebo over 12 weeks. Reductions from baseline in monthly migraine days, headache days of at least moderate severity, and days with acute headache medication use over 12 weeks were significantly greater with quarterly and monthly fremanezumab versus placebo (all P≤0.0103).
The analyses also examined early onset of efficacy and improved headache-related disability, health-related quality-of-life, productivity, and satisfaction in this patient population. Additionally, the analyses looked at cardiovascular adverse events in fremanezumab and placebo treated patients in this group, regardless of whether or not they had a cardiovascular medical history.
Cardiovascular Safety of AJOVY
Additional pooled analyses of the Phase 3 trials were also conducted to examine cardiovascular safety across all patients. The analyses were performed in migraine patients with cardiovascular/cerebrovascular risk factors (e.g., diabetes mellitus, hyperlipidemia, obesity, hypertension, hormonal birth control pill use) (n=499). The overall incidence of cardiovascular adverse events in these patients were low and comparable between fremanezumab and placebo treated groups. An increase in the number of risk factors did not seem to correlate with an increase in frequency of cardiac and vascular adverse events. Additionally, the analyses examined patients with migraine using cardiovascular medications at baseline (n=280), and patients using concomitant triptans (n=1,123) with those who did not use triptans. Similar to the overall trial populations, the most common adverse events reported in all of these subgroups were injection site reactions.
Disease and Economic Burden of Migraine in Europe
Two analyses evaluated the economic and disease burden of migraine across patients in the United Kingdom, France and Spain. The first analysis found that CM patients experienced greater disability caused by migraine versus EM patients. CM patients also reported lower health status than EM patients for their most recent migraine. The second evaluation, which included examining electronic medical records from 84,266 adult patients with EM and CM, found CM patients had more migraine-related consultations with their general practitioners than EM patients. Additionally, average quarterly treatment costs were higher for CM patients in all three countries.
These results point to substantial migraine disability and unmet treatment needs across the three countries. They also associate migraine with a significant healthcare and economic burden that includes higher costs for CM patients.
Accessing Teva EAN Presentations
The ePresentations and ePosters shared by Teva at EAN can be accessed by healthcare professionals through the EAN conference website. The sessions will be available at no cost and will also be on-demand for EAN members from 27 May onward.
Additional resources on migraine, including articles, videos, publications summaries, podcasts and webinars can be accessed on Neurologybytes. Neurologybytes is a platform published by Teva to support neurologists in accessing timely, bite-sized content on the latest research developments and clinical care perspectives in the world of migraine and multiple sclerosis (MS).
Information for Europe about AJOVY®▼can be found here.
▼ Adverse events should be reported.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events. Reporting forms and information can be found at https://www.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.
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 new analysis of fremanezumab Injection 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:
- the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data;
- our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
i Global Burden of Disease 2016 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2017;390:1211–59.
ii Saylor D, Steiner TJ. The Global Burden of Headache. Semin Neurol 2018 Apr;38(2):182-190.
iii Gooch CL, et al. Ann Neurol 2017;81:479–84.
iv Linde M, et al. Eur J Neurol 2012;19:703–11.