Late-breaking poster presentation will examine AJOVY and concomitant gepant use for acute migraine treatment from a retrospective U.S. electronic medical record study
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that eight abstracts examining real-world data to better understand the use of AJOVY® (fremanezumab-vfrm) injection in patients with migraine will be presented at the 2022 American Headache Society (AHS) Annual Meeting held June 9-12, 2022, in Denver, Colorado.
The data presented at this year’s AHS meeting will focus on real-world use of AJOVY across different patient populations. Featured data will include a late-breaking poster presentation on real-world evidence in patients using concomitant gepants for acute migraine treatment, as well as results of a subgroup analysis from the Phase 3b FOCUS study examining the use of AJOVY in patients with difficult-to-treat migraine and comorbid obesity. In addition, a real-world effectiveness study of AJOVY in patients with refractory migraine who switched from erenumab will be highlighted at the meeting.
“June is Migraine and Headache Awareness month, a time that reminds us that while there have been many advances recently in the migraine treatment landscape, there is still work to be done,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “At this year’s AHS meeting, we are looking forward to presenting new real-world research that underscores the impact AJOVY can have on people with specific migraine treatment needs across different clinical circumstances.”
This year’s annual AHS meeting is being offered both in person and virtually. Data presentations can be accessed by registering for the meeting.
The full set of Teva-sponsored AJOVY data to be presented includes:
- Real-World Effectiveness and Tolerability of Fremanezumab for the Preventive Treatment of Migraine in Patients Using Concomitant Gepants for Acute Treatment in a US Neurology Practice (TGT-72562)
- Real-World Effectiveness of Fremanezumab in Patients with Refractory Migraine from a US Tertiary Headache Center Who Switched from Erenumab (TGT-72532)
- Real-World Reductions in Migraine-Related Healthcare Resource Utilization and Medication Use with Fremanezumab Treatment in US Migraine Patients Using Concomitant Acute Gepants (TGT-72533)
- Real-World Impact of Fremanezumab on Migraine-Related Health Care Utilization and Costs in Patients with Common Comorbidities, Acute Medication Overuse, or Difficult-to-Treat Migraine (TGT-72549)
- Reductions in Acute Medication Use, Migraine-Related Health Care Resource Utilization, and Costs for Patients Initiating Fremanezumab: Results of a Long-Term US Claims Database Analysis (TGT-72550)
- Efficacy and Safety of Fremanezumab in Patients with Obesity and Difficult-to-Treat Migraine: Subgroup Analysis of the Randomized, Double-Blind, Phase 3B FOCUS Study (TGT-72561)
- Primary Headache Disorders and Acute Abortive Medications Associated with Patients Diagnosed with Medication Overuse Headache: Analysis of German EMR Data (TGT-73146)
- Response to Fremanezumab for Preventive Treatment in Migraine in Routine Clinical Practice: First Data from the FINESSE study (TGT-72567)
About AJOVY (fremanezumanb-vfrm) Injection
AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe or autoinjector with two dosing options – 225 mg administered monthly as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. AJOVY is now approved in 45 countries worldwide.
Indications and Usage
AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
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.
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 the governmental and societal responses thereto; 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 Quarterly Report on Form 10-Q for the first quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, 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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