Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that 8 presentations examining Phase 2b/3 data, pooled analyses and open-label extension (OLE) study data for AJOVY (fremanezumab-vfrm) injection will be presented at the 25th World Congress of Neurology (WCN), taking place virtually on Oct. 3-7, 2021.
“The data being presented at this year's WCN meeting aid in expanding our knowledge of migraine so we can continue to better understand this treatment option,” said Matthias Mueller, MD MSc, VP Global Medical Affairs at Teva.
Featured data include pooled analyses of different trials examining outcomes related to efficacy and safety, quality of life and disability in patients with different migraine frequency, patients who have inadequate response to previous preventive treatments, patients within different ethnic subgroups and patients with medication overuse headache.
Addressing healthcare disparities within migraine treatment is a key area of focus. A recent review of literature published in Neurology shows how disparities in race, ethnicity, socioeconomic status, geography, and other factors contribute to the inequitable treatment of those diagnosed with headache disorders.1
Teva will host an online symposium, “Envisioning a More Inclusive, Diverse and Equitable Global Migraine Landscape: Are We Making Progress?” on Oct. 3, from 14:00 – 15:30 CEST. The symposium will be led by Cristina Tassorelli (Chair), with Larry Charleston, Cynthia Armand, Bronwyn Jenkins and Gisela Terwindt, discussing disparities in healthcare and neurology, underrepresentation in neurology and migraine clinical trials, and data on the efficacy and safety of anti-CGRP mAbs in patients with different demographic and non demographic characteristics. This session will also be available for on-demand viewing following the live session.
The symposium is designed to address the following objectives:
- Build awareness of healthcare disparities as a major public health issue by highlighting social determinants of health and defining concepts and terms relevant to understanding health disparities and diversity
- Critique the state of diversity in migraine clinical studies, review barriers to recruitment, and discuss the need for more inclusive and diverse studies
- Examine inclusivity of anti-CGRP mAb clinical studies specifically, and review latest data from diverse sub-populations, e.g. different ethnicities, migraine characteristics and comorbidities
“To help ensure migraine patients are receiving the care they need, it's important to understand all factors that contribute to a person’s health and disease state. Both demographic and non demographic factors are important to consider when treating our patients. We are excited to lead this conversation to help build awareness around health disparities to ensure more equity in neurology treatment,” said Matthias Mueller, MD MSc, VP Global Medical Affairs at Teva.
The full set of abstracts approved by the congress scientific committee and sponsored by Teva include:
De novo
- “Fremanezumab Improves Quality of Life in Patients With Higher- and Lower-Frequency Chronic Migraine”
- “Fremanezumab Improves Quality of Life in Patients With High- and Moderate-Frequency Episodic Migraine”
- “Efficacy and Improvements in Disability and Quality-of-Life With Fremanezumab Over 6 Months in Migraine Patients With Inadequate Response by Multiple Prior Preventive Treatment Classes”
- “Reversion From Medication Overuse With Fremanezumab Treatment in Patients With Inadequate Response to Multiple Migraine Preventive Medication Classes”
- “Progressive Improvements in Efficacy and Disability With Fremanezumab in Patients With Medication Overuse And Inadequate Response to Multiple Migraine Preventive Medication Classes”
- “Efficacy Of Fremanezumab in Patients With Chronic and Episodic Migraine Stratified by Migraine Frequency”
- “Efficacy And Tolerability of Fremanezumab for Migraine Preventive Treatment in Korean Patients With Chronic or Episodic Migraine”
- “Pooled Analysis of Safety and Efficacy of Fremanezumab in Different Racial and Ethnic Subgroups of Patients With Migraine”
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.
U.S. Important Safety Information about AJOVY (fremanezumab-vfrm) injection
Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.
Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions in clinical trials (≥5% and greater than placebo) were injection site reactions.
Please click here for full U.S. Prescribing Information for AJOVY (fremanezumab-vfrm) injection.
About Teva
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.
1 Kiarashi J, VanderPluym J, Szperka CL, et al. Factors associated with, and mitigation strategies for, healthcare disparities faced by patients with headache disorders. Neurology. Published online June 9, 2021. doi:10.1212/WNL.0000000000012261.
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