New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting
Teva Pharmaceuticals has released results from a retrospective U.S. study demonstrating the effectiveness of AJOVY (fremanezumab-vfrm) in reducing monthly migraine days when used with gepants for acute treatment. At study initiation, patients averaged 15.8 monthly migraine days, which decreased by 6.5 days (41.1% reduction) post-treatment. This data, presented at the 2022 AHS Annual Meeting, highlights AJOVY's potential in managing migraines across diverse patient populations. However, 9.1% of patients reported adverse events, including injection site reactions and uveitis.
- 41.1% reduction in monthly migraine days observed in study participants.
- AJOVY is now approved in 45 countries, indicating strong global acceptance.
- Study highlights the combination treatment's effectiveness in diverse patient populations.
- 9.1% of patients experienced adverse events post-treatment.
- Potential risks related to hypersensitivity reactions were noted in the safety information.
Findings from a retrospective
Data presentations at AHS included eight abstracts examining real-world use of AJOVY across different patient populations and clinical circumstances. In an additional poster presentation, 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 were reported. The real-world effectiveness of fremanezumab in patients with refractory migraine from a US tertiary headache center who switched from erenumab study was also highlighted.
“The breadth of real-world evidence presented at this year’s AHS meeting across different patient populations and practice settings underscores the value of AJOVY in helping to manage this disabling neurological disease,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “As the migraine treatment landscape continues to advance, these data provide important insights about AJOVY in real-world settings and its use as a migraine preventive treatment across a spectrum of patients.”
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
The US retrospective chart review study examined data from electronic medical records of 55 adult patients (age 18 and older) from the
At the time of AJOVY initiation, patients had an average (standard deviation) of 15.8 (7.4) MMD. The average time from the index date to the last visit was 9.4 (4.5) months. The average change in MMD from the index to the post-index date was -6.5 (1.0) days, representing a
“Millions of people suffer from migraine and its debilitating effects, and finding the right treatment combination can be challenging. Different treatment approaches can be used synergistically, but given that these are relatively new treatments, real-world data on the concomitant use of AJOVY and gepants is limited,” said
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.
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. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.
Adverse Reactions: The most common adverse reactions (≥
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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
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