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Teva SPACE Pediatric Phase 3 Study Met Its Primary End Point For Efficacy With A Significantly Greater Reduction In Monthly Migraine Days Compared To Placebo; Efficacy Is Consistent With AJOVY Pivotal Phase 3 And Real-World Evidence Studies In Adults...

Benzinga ·  20:36

Teva SPACE Pediatric Phase 3 Study Met Its Primary End Point For Efficacy With A Significantly Greater Reduction In Monthly Migraine Days Compared To Placebo; Efficacy Is Consistent With AJOVY Pivotal Phase 3 And Real-World Evidence Studies In Adults With No New Emergent Safety Signals Observed

  • SPACE pediatric Phase 3 study met its primary end point for efficacy with a significantly greater reduction in Monthly Migraine Days compared to placebo
  • Efficacy is consistent with AJOVY(fremanezumab) pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
  • Full data to be presented at a medical meeting later in 2024

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today positive topline results from its Phase 3 SPACE study evaluating the efficacy of AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. Safety data was consistent with that observed in adult populations, with no emergent safety signals. Full data from the SPACE study will be presented at a medical meeting later this year.

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