Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention
- If approved for an expanded pediatric indication, AJOVY would be the first calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients, addressing the high unmet need for effective treatments
- AJOVY is currently the only anti-CGRP treatment for migraine prevention in adults in the U.S. that is available in both quarterly and monthly dosing options1
- These efforts underscore Teva's dedication to expanding access to innovative neuroscience treatments for diverse patient populations
PARSIPPANY, N.J. and TEL AVIV, April 07, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. If approved, AJOVY would be the only calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients, helping to address the high unmet need for effective treatments for those living with migraine.
"Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "As we work to bring the benefits of AJOVY to younger patients, we build upon its proven success in adults. If approved, AJOVY could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population."
The application was based on positive results from the Phase 3 SPACE trial, which evaluated the efficacy and safety of AJOVY for the prevention of episodic migraine in pediatric patients. The trial demonstrated statistically significant improvements in reducing monthly migraine days and monthly headache days compared to placebo, with a safety profile consistent with that observed in the adult population.2
AJOVY was approved in the U.S. for the preventive treatment of migraines in adults in 2018.3 AJOVY is also approved in Europe and several other international markets, including Canada, Australia and Japan. As an anti-CGRP treatment, it targets the underlying causes of migraines and has demonstrated consistent efficacy in reducing the frequency and severity of attacks in adults.
About SPACE
SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12-week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.
About AJOVY
AJOVY is indicated for preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. For full prescribing information, visit https://www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf
About Migraine
Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks.4 Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities.5
INDICATION AND USAGE
AJOVY (fremanezumab-vfrm) injection is indicated for the preventive treatment of migraine in adults.
IMPORTANT SAFETY INFORMATION
Contradictions: 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.
Hypertension: Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including AJOVY, in the postmarketing setting.
Monitor patients treated with AJOVY for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of AJOVY is warranted.
Raynaud's Phenomenon: Development of Raynaud's phenomenon and recurrence or worsening of pre- existing Raynaud's phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including AJOVY. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain.
AJOVY should be discontinued if signs or symptoms of Raynaud's phenomenon develop. Patients with a history of Raynaud's phenomenon should be monitored for, and informed about the possibility of,
worsening or recurrence of signs and symptoms.
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) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company's global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients' needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit 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: our ability to successfully develop and commercialize AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescents; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2024, including in the section captioned "Risk Factors" and "Forward Looking Statements." 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.
- AJOVY (fremanezumab-vfrm) injection, for subcutaneous use. Current Prescribing Information. Parsippany, NJ. Teva Neuroscience, Inc.
- Hershey, A., et al. Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic Migraine in Children and Adolescents: a Phase 3, Randomised, Double-Blind, Placebo-Controlled Study. Presented at European Headache Congress (EHC); 4-7 December 2024, Rotterdam. ePoster LP036.
- Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
- Jaimie D Steinmetz, Katrin Seeher, Nicoline Schiess, Emma Nichols, Bochen Cao, Chiara Servili, Vanessa Cavallera, Christopher J L Murray, Kanyin Liane Ong, Valery L Feigin, Theo Vos, and Tarun Dua on behalf of the GBD network. Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Neurol. (in press).
- Pediatric Migraine, An Update. Greene, Kaitlin. et al; Neurology clinics, Volume 37, Issue 4, 815-833. August 31, 2019. https://doi.org/10.1016/j.ncl.2019.07.009
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