TEL AVIV, Israel & PARSIPPANY, N.J. - Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced results from a network meta-analysis examining the efficacy of AJOVY (fremanezumab-vfrm), atogepant and Nurtec ODT (rimegepant) in the preventive treatment of episodic migraine (EM). This data will be presented as a late-breaker ePoster during the International Headache Society (IHS) and European Headache Federation (EHF) Joint Congress taking place virtually on Sept. 8-12, 2021.
AJOVY is the first and only long-acting (defined as efficacy measured over a 12-week period following a 675 mg [225 mg x 3] subcutaneous dose) anti-CGRP subcutaneous injection approved for the preventive treatment of migraine in adults with both quarterly and monthly dosing options.1++/-
Migraine is a disabling chronic neurological disease that causes head pain and associated symptoms so severe that people often cannot function during an attack. Migraine reduces quality of life and disrupts the lives of those suffering from migraine and their ability to perform daily activities.2,1 It is among the top 10 causes of disability worldwide.2
'As migraine is so prevalent affecting one billion people worldwide3, it's important for us to explore fremanezumab's full treatment potential to ensure we're offering patients an option to help prevent their migraine attacks,' said Matthias Mueller, MD MSc, VP Global Medical Affairs at Teva. 'We're pleased to see the migraine treatment landscape continue to advance, and these latest data provide clinicians with new insights into the impact of choosing a treatment option for each individual patient, reducing this migraine burden for patients.'
The meta-analysis indirectly assessed changes from baseline in monthly migraine days (MMD) and 50 percent reduction from baseline in MMD for patients receiving AJOVY, atogepant and rimegepant compared to placebo.
Additional retrospective post hoc analyses were conducted to understand migraine and headache frequency and severity for chronic migraine (CM) and EM patients who were treated with AJOVY. The analyses included patients who were initially enrolled in the Phase 3 HALO and FOCUS clinical programs. No determination of statistical significance can be made, and individual results may vary. No new safety signals were identified against the known safety profile of AJOVY.
Late-Breaker ePoster: Network Meta-analysis on Monthly Migraine Day Reductions with Fremanezumab, Rimegepant, and Atogepant in the Prevention of Episodic Migraine
This meta-analysis assessed relative efficacy for AJOVY monthly (MLY) and quarterly (QLY) dosing, atogepant daily (QD) and twice-daily (BID) dosing, and rimegepant every-other-day (QOD) dosing in the preventive treatment of EM.
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, 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. You can identify these forward-looking statements by the use of words such as 'should,' 'expect,' 'anticipate,' 'estimate,' 'target,' 'may,' 'project,' 'guidance,' 'intend,' 'plan,' 'believe' and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO, AJOVY and COPAXONE; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, 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, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the section captioned 'Risk Factors.' 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.
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