Teva to present 8 summaries on AJOVY® injection (fremanezumab-vfrm) and host a symposium on health care disparities at WCN
TEL AVIV, Israel & PARSIPPANY, NJ – (COMMERCIAL THREAD) – Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that 8 presentations reviewing Phase 2b / 3 data, pooled analyzes, and open-label extension study (OLE) data for AJOVY injection ( fremanezumab-vfrm) will be presented at the 25e World Congress of Neurology (WCN), to be held virtually from October 3-7, 2021.
“The data presented at this year’s WCN meeting helps us expand our knowledge about migraine so that we can continue to better understand this treatment option,” said Matthias Mueller, MD MSc, VP Global Medical Affairs at Teva .
The data presented include pooled analyzes of different trials examining the results related to efficacy and safety, quality of life and disability in patients with different frequencies of migraine, patients who have an inadequate response to treatments. preventive drugs, patients of different ethnic subgroups and patients with headache from drug abuse.
Addressing health care disparities in the treatment of migraine is a key area. A recent review of the literature published in Neurology shows how disparities in race, ethnicity, socioeconomic status, geography and other factors contribute to the unfair treatment of those diagnosed with headache disorders.1
Teva will be hosting an online symposium titled “Envisioning a More Inclusive, Diverse, and Equitable Global Migraine Landscape: Are We Making Progress?” »October 3, 2:00 p.m. to 3:30 p.m. CEST. The symposium will be chaired by Cristina Tassorelli (Chair), with Larry Charleston, Cynthia Armand, Bronwyn Jenkins and Gisela Terwindt, discussing disparities in healthcare and neurology, under-representation in clinical trials in neurology and against migraine, and data on the efficacy and safety of anti-MAb CGRP in patients with different demographic and non-demographic characteristics. This session will also be available for on-demand viewing after the live session.
The symposium is designed to meet the following objectives:
Raise awareness of health care disparities as a major public health problem by highlighting the 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, examine barriers to recruitment, and discuss the need for more inclusive and diverse studies
Specifically examine the inclusiveness of anti-CGRP mAb clinical studies and review the latest data from various subpopulations e.g. different ethnicities, migraine characteristics and co-morbidities
“To ensure that migraine patients receive the care they need, it is important to understand all of the factors that contribute to a person’s state of health and illness. Both demographic and non-demographic factors are important to consider when treating our patients. We are excited to be leading this conversation to help raise awareness of health disparities to ensure greater equity in treatment in neurology, ”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:
“Fremanezumab improves the quality of life of patients with chronic high and low frequency migraine”
“Fremanezumab improves the quality of life of patients with high and moderate episodic migraine”
“Efficacy and improvement of disability and quality of life with fremanezumab over 6 months in patients with migraine with inadequate response by several classes of previous preventive treatment”
“Reversal of drug overuse with fremanezumab treatment in patients with an inadequate response to several classes of migraine preventive drugs”
“Progressive improvements in efficacy and disability with fremanezumab in patients with drug overuse and inadequate response to several classes of migraine preventive drugs”
“Efficacy of fremanezumab in patients with chronic and episodic migraine stratified by migraine frequency”
“Efficacy and safety of fremanezumab for the preventive treatment of migraine in Korean patients suffering from chronic or episodic migraine”
“Pooled review of the safety and efficacy of fremanezumab in different racial and ethnic subgroups of patients with migraine”
Information for Europe on AJOVY?? can be found here.
Adverse events should be reported.
This medicine is subject to additional monitoring. This will allow rapid identification of new security information. Healthcare professionals are urged to report any suspected adverse events. Declaration forms and information are available at https://www.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.
Important US Safety Information Regarding Injecting AJOVY (fremanezumab-vfrm)
Contraindications: AJOVY is contraindicated in patients with severe hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions included anaphylaxis and angioedema.
Hypersensitivity reactions: Hypersensitivity reactions including rash, pruritus, drug hypersensitivity and urticaria have been reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some resulted in discontinuation of treatment or required corticosteroid therapy. Most reactions were reported a few hours to a month after administration. Cases of anaphylaxis and angioedema have been reported in the post-marketing experience. If a hypersensitivity reaction occurs, consider stopping AJOVY and institute appropriate treatment.
Side effects: The most common adverse reactions in clinical trials (≥ 5% and greater than placebo) were injection site reactions.
Please click here for full US prescribing information for AJOVY (fremanezumab-vfrm) injection.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) have been developing and producing drugs to improve people’s lives for over a century. We are a global leader in generic and specialty drugs with a portfolio of more than 3,500 products in almost all therapeutic areas. About 200 million people around the world take a Teva medicine every day and are served by one of the pharmaceutical industry’s largest and most complex supply chains. In addition to our established presence in generics, we have significant innovative research and operations activities supporting our growing portfolio of specialty and biopharmaceutical products. Learn more about www.tevapharm.com.
Caution 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 the current beliefs and expectations of management and are subject to substantial risks and uncertainties, known and unknown, which could cause our results. future. , performance or achievements differ materially from those expressed or implied by such forward-looking statements. You can identify these forward-looking statements by using words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “plan”, “guide”, ” intend, “Significant factors that could cause or contribute to such differences include risks to AJOVY’s business success; our ability to compete successfully in the market, including our ability to develop and commercialize biopharmaceuticals, competition for our specialty products, including AUSTEDO®, AJOVY and COPAXONE®; our ability to achieve expected results from investments in our product portfolio, 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 debt; our business and operations in general, including the uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flow and liquidity and on the economy in general, our ability to successfully execute and maintain activities and efforts related to actions we have taken or may take in response to the COVID-19 pandemic and the associated costs, costs and delays resulting from extended drug regulation to which we are subject or delays in government processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including non-compliance 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 titled “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 place undue reliance on these forward-looking statements.
1 Kiarashi J, VanderPluym J, Szperka CL, et al. Associated factors and mitigation strategies for health care disparities experienced by patients with headache. Neurology. Published online June 9, 2021. doi: 10.1212 / WNL.00000000000012261.