Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention
Teva Pharmaceuticals (NYSE: TEVA) announced the FDA's acceptance of its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab) to expand its use to pediatric episodic migraine prevention in patients aged 6-17 years weighing 45kg or more.
The application is supported by positive Phase 3 SPACE trial results, which showed statistically significant improvements in reducing monthly migraine and headache days versus placebo. If approved, AJOVY would become the first calcitonin gene-related peptide (CGRP) antagonist for both adult migraine prevention and pediatric episodic migraine prevention.
AJOVY, initially approved in the U.S. in 2018 for adult migraine prevention, is currently the only anti-CGRP treatment available in both quarterly and monthly dosing options. The treatment is also approved in Europe, Canada, Australia, and Japan.
Teva Pharmaceuticals (NYSE: TEVA) ha annunciato l'accettazione da parte della FDA della sua domanda supplementare di licenza biologica (sBLA) per AJOVY® (fremanezumab) al fine di espandere il suo utilizzo nella prevenzione dell'emicrania episodica pediatrica in pazienti di età compresa tra 6 e 17 anni che pesano 45 kg o più.
La domanda è supportata dai risultati positivi dello studio di fase 3 SPACE, che hanno mostrato miglioramenti statisticamente significativi nella riduzione dei giorni di emicrania e mal di testa mensili rispetto al placebo. Se approvato, AJOVY diventerebbe il primo antagonista del peptide correlato al gene della calcitonina (CGRP) sia per la prevenzione dell'emicrania negli adulti che per la prevenzione dell'emicrania episodica pediatrica.
AJOVY, inizialmente approvato negli Stati Uniti nel 2018 per la prevenzione dell'emicrania negli adulti, è attualmente l'unico trattamento anti-CGRP disponibile sia in opzioni di dosaggio trimestrale che mensile. Il trattamento è inoltre approvato in Europa, Canada, Australia e Giappone.
Teva Pharmaceuticals (NYSE: TEVA) anunció la aceptación por parte de la FDA de su solicitud suplementaria de licencia biológica (sBLA) para AJOVY® (fremanezumab) con el fin de ampliar su uso en la prevención de la migraña episódica pediátrica en pacientes de 6 a 17 años que pesen 45 kg o más.
La solicitud está respaldada por los resultados positivos del ensayo clínico de fase 3 SPACE, que mostraron mejoras estadísticamente significativas en la reducción de los días de migraña y dolor de cabeza mensuales en comparación con el placebo. Si se aprueba, AJOVY se convertiría en el primer antagonista del péptido relacionado con el gen de la calcitonina (CGRP) tanto para la prevención de la migraña en adultos como para la prevención de la migraña episódica pediátrica.
AJOVY, aprobado inicialmente en EE. UU. en 2018 para la prevención de la migraña en adultos, es actualmente el único tratamiento anti-CGRP disponible tanto en opciones de dosificación trimestral como mensual. El tratamiento también está aprobado en Europa, Canadá, Australia y Japón.
테바 제약 (NYSE: TEVA)는 AJOVY® (프레마네주맙)의 보완 생물학적 라이센스 신청서(sBLA)가 FDA에 의해 수용되었다고 발표했습니다. 이는 6세에서 17세 사이의 환자 중 체중이 45kg 이상인 소아의 에피소드성 편두통 예방으로 사용을 확대하기 위한 것입니다.
이 신청서는 위약 대비 월간 편두통 및 두통 일수를 줄이는 데 있어 통계적으로 유의미한 개선을 보여준 긍정적인 3상 SPACE 시험 결과에 의해 지원됩니다. 만약 승인이 된다면, AJOVY는 성인 편두통 예방과 소아 에피소드성 편두통 예방 모두를 위한 첫 번째 칼시토닌 유전자 관련 펩타이드(CGRP) 길항제가 될 것입니다.
AJOVY는 2018년 성인 편두통 예방을 위해 미국에서 처음 승인되었으며, 현재 분기 및 월간 투여 옵션 모두에서 사용 가능한 유일한 항-CGRP 치료제입니다. 이 치료제는 유럽, 캐나다, 호주 및 일본에서도 승인되었습니다.
Teva Pharmaceuticals (NYSE: TEVA) a annoncé l'acceptation par la FDA de sa demande de licence biologique supplémentaire (sBLA) pour AJOVY® (fremanezumab) afin d'élargir son utilisation à la prévention de la migraine épisodique pédiatrique chez les patients âgés de 6 à 17 ans pesant 45 kg ou plus.
La demande est soutenue par des résultats positifs de l'essai de phase 3 SPACE, qui ont montré des améliorations statistiquement significatives dans la réduction des jours de migraine et de maux de tête mensuels par rapport au placebo. Si elle est approuvée, AJOVY deviendrait le premier antagoniste du peptide lié au gène de la calcitonine (CGRP) pour la prévention de la migraine chez les adultes et la prévention de la migraine épisodique chez les enfants.
AJOVY, initialement approuvé aux États-Unis en 2018 pour la prévention de la migraine chez les adultes, est actuellement le seul traitement anti-CGRP disponible en options de dosage trimestriel et mensuel. Le traitement est également approuvé en Europe, au Canada, en Australie et au Japon.
Teva Pharmaceuticals (NYSE: TEVA) gab bekannt, dass die FDA ihren Antrag auf ergänzende biopharmazeutische Lizenz (sBLA) für AJOVY® (fremanezumab) angenommen hat, um die Anwendung zur Prävention von episodischen Migräne bei Kindern im Alter von 6 bis 17 Jahren mit einem Gewicht von 45 kg oder mehr zu erweitern.
Der Antrag wird durch positive Ergebnisse der Phase-3-Studie SPACE unterstützt, die statistisch signifikante Verbesserungen bei der Reduzierung der monatlichen Migräne- und Kopfschmerztage im Vergleich zu Placebo zeigte. Wenn genehmigt, würde AJOVY der erste Antagonist des calcitonin-genverwandten Peptids (CGRP) sowohl zur Prävention von Migräne bei Erwachsenen als auch zur Prävention von episodischer Migräne bei Kindern werden.
AJOVY, das 2018 in den USA zur Prävention von Migräne bei Erwachsenen zugelassen wurde, ist derzeit die einzige anti-CGRP-Behandlung, die sowohl in vierteljährlichen als auch in monatlichen Dosierungsoptionen verfügbar ist. Die Behandlung ist auch in Europa, Kanada, Australien und Japan zugelassen.
- First potential CGRP antagonist for both adult and pediatric migraine prevention
- Successful Phase 3 SPACE trial results showing significant efficacy
- Unique market position with both quarterly and monthly dosing options
- Geographic expansion with approvals in multiple major markets
- FDA approval still pending, creating market uncertainty
- Weight restriction limits addressable pediatric patient population to 45kg+
Insights
The FDA's acceptance of Teva's supplemental Biologics License Application (sBLA) for AJOVY represents a significant regulatory milestone in the company's strategy to expand its migraine franchise. This is the first official step toward potential approval for pediatric episodic migraine prevention in children and adolescents aged 6-17 who meet the weight requirement.
The regulatory significance here is substantial - if approved, AJOVY would secure the first-in-class position for a CGRP antagonist in the pediatric migraine space. The FDA's acceptance indicates the application has satisfied basic requirements to proceed through the review process, though final approval remains contingent on the agency's comprehensive evaluation of efficacy and safety.
The Phase 3 SPACE trial results cited in the submission demonstrated statistically significant improvements in both monthly migraine days and headache days compared to placebo, with a safety profile consistent with adult usage. This data strengthens the application's prospects.
From a regulatory perspective, expanding approved indications to include pediatric populations is strategically valuable, potentially extending market exclusivity periods while addressing FDA initiatives to increase approved treatment options for younger patients. The acceptance keeps Teva on track toward potentially securing this competitive advantage in the underserved pediatric migraine market.
This FDA filing acceptance positions Teva to potentially capture a valuable untapped segment in the migraine prevention market. Pediatric migraine represents a substantial unmet medical need, with treatment options significantly more than in the adult space.
If approved, AJOVY would gain a competitive differentiation against other CGRP antagonists by being the only option with a pediatric indication. This first-mover advantage in the pediatric segment could strengthen AJOVY's overall market position against competitors like Aimovig (Amgen/Novartis) and Emgality (Eli Lilly).
The flexible dosing options (quarterly and monthly) mentioned in the article represent another potential advantage in the pediatric market, where administration frequency can impact compliance and patient/parent preference.
While not quantified in the article, expanding into the pediatric population would open access to a meaningful patient population, potentially driving additional revenue for this established product first approved in 2018. This regulatory progress aligns with Teva's broader strategy to maximize value from its neuroscience portfolio.
For Teva, with a market cap of approximately
- 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 (≥
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
Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquires
TevaIR@Tevapharm.com
FAQ
What is the potential market expansion for TEVA's AJOVY with the new pediatric indication?
What were the key results from TEVA's Phase 3 SPACE trial for pediatric AJOVY?
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What age group and weight requirement is TEVA targeting for the new AJOVY indication?
