Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial
Teva Pharmaceutical announced positive Phase 3 SPACE trial results for AJOVY® (fremanezumab) in preventing episodic migraine in children and adolescents aged 6-17 years. The study demonstrated significant reductions in monthly migraine days (-2.5 vs -1.4; p=0.0210) and monthly headache days (-2.6 vs -1.5; p=0.0172) compared to placebo over 12 weeks.
The trial involved 237 participants with episodic migraine, showing a higher response rate of 47.2% vs 27.0% for placebo (p=0.0016). The treatment demonstrated favorable safety, with similar adverse event rates between treatment (55%) and placebo (49%) groups. Benefits were consistent across age subgroups and genders, marking the first successful Phase 3 trial of a CGRP-pathway treatment for pediatric migraine prevention.
Teva Pharmaceutical ha annunciato risultati positivi della fase 3 dello studio SPACE per AJOVY® (fremanezumab) nella prevenzione dell'emicrania episodica in bambini e adolescenti di età compresa tra 6 e 17 anni. Lo studio ha dimostrato riduzioni significative nei giorni di emicrania mensili (-2.5 contro -1.4; p=0.0210) e nei giorni di mal di testa mensili (-2.6 contro -1.5; p=0.0172) rispetto al placebo nell'arco di 12 settimane.
Lo studio ha coinvolto 237 partecipanti con emicrania episodica, mostrando un tasso di risposta più elevato del 47.2% contro il 27.0% per il placebo (p=0.0016). Il trattamento ha dimostrato un profilo di sicurezza favorevole, con tassi di eventi avversi simili tra i gruppi di trattamento (55%) e placebo (49%). I benefici sono stati coerenti tra i sottogruppi di età e i sessi, segnando il primo trial di fase 3 di successo per un trattamento delle vie CGRP nella prevenzione dell'emicrania pediatrica.
Teva Pharmaceutical anunció resultados positivos del ensayo de fase 3 SPACE para AJOVY® (fremanezumab) en la prevención de la migraña episódica en niños y adolescentes de 6 a 17 años. El estudio demostró reducciones significativas en los días mensuales de migraña (-2.5 vs -1.4; p=0.0210) y en los días mensuales de dolor de cabeza (-2.6 vs -1.5; p=0.0172) en comparación con el placebo durante 12 semanas.
El ensayo incluyó a 237 participantes con migraña episódica, mostrando una tasa de respuesta más alta del 47.2% frente al 27.0% para el placebo (p=0.0016). El tratamiento demostró una seguridad favorable, con tasas de eventos adversos similares entre los grupos de tratamiento (55%) y placebo (49%). Los beneficios fueron consistentes entre los subgrupos de edad y géneros, marcando el primer ensayo exitoso de fase 3 para un tratamiento de la vía CGRP en la prevención de la migraña pediátrica.
테바 제약이 AJOVY® (프레마네주맙)의 3상 SPACE 시험 결과가 6-17세의 아동과 청소년에서 일차두통 예방에 긍정적임을 발표했습니다. 연구 결과, 12주 동안 위약에 비해 월간 두통 감소가 유의미한 것으로 나타났습니다 (-2.5 대 -1.4; p=0.0210) 및 월간 두통 감소 (-2.6 대 -1.5; p=0.0172).
이번 시험에는 237명의 일차두통 환자가 포함되었으며, 치료 group's Response rate는 47.2%로 위약의 27.0%를 초과했습니다 (p=0.0016). 치료는 안전성 측면에서 유리한 결과를 보였으며, 치료군 (55%)과 위약군 (49%) 사이의 부작용 발생률이 유사했습니다. 연령 및 성별 하위 그룹에서도 일관된 효과를 보였으며, 소아 두통 예방을 위한 CGRP 경로 치료의 첫 번째 성공적인 3상 시험으로 기록되었습니다.
Teva Pharmaceutical a annoncé des résultats positifs de l'essai de phase 3 SPACE pour AJOVY® (fremanezumab) dans la prévention de la migraine épisodique chez des enfants et des adolescents âgés de 6 à 17 ans. L'étude a démontré des réductions significatives des jours de migraine mensuels (-2,5 contre -1,4; p=0,0210) et des jours de maux de tête mensuels (-2,6 contre -1,5; p=0,0172) par rapport au placebo sur 12 semaines.
L'essai a inclus 237 participants souffrant de migraine épisodique, montrant un taux de réponse plus élevé de 47,2 % contre 27,0 % pour le placebo (p=0,0016). Le traitement a montré une sécurité favorable, avec des taux d'événements indésirables similaires entre le groupe de traitement (55 %) et le groupe placebo (49 %). Les avantages étaient cohérents entre les sous-groupes d'âge et de sexe, marquant le premier essai de phase 3 réussi d'un traitement par voie CGRP pour la prévention de la migraine pédiatrique.
Teva Pharmaceutical gab positive Ergebnisse der Phase-3-Studie SPACE für AJOVY® (Fremanezumab) zur Prävention episodischer Migräne bei Kindern und Jugendlichen im Alter von 6 bis 17 Jahren bekannt. Die Studie zeigte signifikante Reduktionen der monatlichen Migränetage (-2,5 gegenüber -1,4; p=0,0210) und der monatlichen Kopfschmerztage (-2,6 gegenüber -1,5; p=0,0172) im Vergleich zu Placebo über 12 Wochen.
Die Studie umfasste 237 Teilnehmer mit episodischer Migräne und zeigte eine höhere Antwortquote von 47,2 % gegenüber 27,0 % für Placebo (p=0,0016). Die Behandlung erwies sich als sicher, mit ähnlichen Raten von unerwünschten Ereignissen zwischen den Behandlungsgruppen (55 %) und der Placebogruppe (49 %). Die Vorteile waren in den Alters- und Geschlechtsuntergruppen konsistent, was die erste erfolgreiche Phase-3-Studie eines CGRP-Wegbehandlungsansatzes zur Prävention von Migräne bei Kindern kennzeichnet.
- Statistically significant reduction in monthly migraine days vs placebo (-2.5 vs -1.4)
- Significantly higher 50% response rate vs placebo (47.2% vs 27.0%)
- Favorable safety profile with low discontinuation rate (≤1%)
- First successful Phase 3 CGRP-pathway treatment for pediatric migraine prevention
- None.
Insights
The Phase 3 SPACE trial results represent a significant advancement in pediatric migraine treatment. The data shows statistically significant reductions in both monthly migraine days (-2.5 vs -1.4) and monthly headache days (-2.6 vs -1.5) compared to placebo. Particularly noteworthy is the 47.2% response rate in achieving 50% reduction in migraine days versus 27.0% for placebo.
The favorable safety profile, with comparable adverse event rates between treatment and placebo groups (55% vs 49%) and low discontinuation rates (<1%) suggest good tolerability in the pediatric population. This is important for long-term adherence in chronic conditions. The consistent efficacy across age groups (6-11 and 12-17 years) and genders broadens the potential patient base significantly.
This trial positions Teva strategically in the underserved pediatric migraine market. With a 7.7% prevalence rate in children, increasing to 15% in adolescents, this represents a substantial market opportunity. AJOVY being the first CGRP-pathway treatment showing efficacy in pediatric patients gives Teva a significant first-mover advantage in this segment.
The positive trial results could lead to expanded indications and market share growth, particularly important given the treatment options currently available for pediatric migraine. This could translate into meaningful revenue growth, as successful pediatric indications often lead to increased adoption among adult patients due to enhanced safety confidence.
- AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in pediatric patients aged 6-17 years1
- Efficacy consistent with fremanezumab pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
- Full data presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam, Netherlands
TEL AVIV, Israel, Dec. 04, 2024 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) presented positive data from its Phase 3 SPACE study evaluating the efficacy and safety of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years.1 The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favourable safety profile1 consistent with that observed in the adult population.
Migraine is common among children, with an overall estimated prevalence of
One of the lead investigators of the trial, Professor Patricia Pozo-Rosich, Headache Unit and Research Group, Head of Section Neurology Department at Vall d’Hebron Hospital and Research Institute, Barcelona said “This is an important milestone for clinicians and young patients living with episodic migraine who currently have little treatment options available to them. This is the first Phase 3 trial of a CGRP-pathway treatment that has shown statistically superior efficacy with favourable safety and tolerability for the prevention of episodic migraine in children and adolescents.”
SPACE is a multicentre, double-blind study evaluating the efficacy and safety of fremanezumab in 237 children and adolescents with episodic migraine aged 6-17 years. The pediatric study participants had been diagnosed with migraine for 6 months or more, with a history of less than 14 headache days a month. The trial included subgroup analyses by age (6 -11 years and 12 -17 years) and by sex.1
Highlights from the SPACE data showed that over 3 months fremanezumab achieved:1
- Significant reduction in monthly migraine days (MMD) vs placebo (-2.5 vs -1.4; p=0.0210)
- Significant reduction in monthly headache days (MHD) vs placebo (-2.6 vs -1.5; p=0.0172)
- Significantly higher number of children achieving a
50% response rate vs placebo (47.2% vs27.0% ; p=0.0016) - Benefits were similar in both the age subgroups and between boys and girls
Fremanezumab also demonstrated a favourable safety profile, and was well tolerated with no safety signals:1
- Proportion of children reporting ≥1 adverse events (AEs) was similar between the treatment group vs placebo (
55% vs49% ) - Proportion of patients with serious adverse events (SAEs) and AEs leading to treatment discontinuation was low at ≤
3% and ≤1% respectively
“Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licenced treatments to manage this debilitating condition in children.” said Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals. "We’ve already seen the benefits of AJOVY in adults and the SPACE trial has confirmed that children with episodic migraine can also benefit from AJOVY. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden.”
Teva continues to study the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety.
About SPACE
SPACE is a multicentre, randomised, 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 prophylaxis of migraine in adults who have at least 4 migraine days per month. 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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. 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 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. 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, in our quarterly report on Form 10-Q for the third quarter of 2024, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections 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.
1 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.
2 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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