Teva (TEVA) presented data from its Phase 3 SPACE study evaluating the efficacy and safety of Ajovy for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favorable safety profile consistent with that observed in the adult population. SPACE is a multicenter, 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 six months or more, with a history of less than 14 headache days a month. The trial included subgroup analyses by age and by sex. Highlights from the SPACE data showed that over three months fremanezumab achieved: significant reduction in monthly migraine days vs. placebo; significant reduction in monthly headache days vs. placebo; significantly higher number of children achieving a 50% response rate vs. placebo; benefits were similar in both the age subgroups and between boys and girls. Fremanezumab also demonstrated a favorable safety profile, and was well tolerated with no safety signals: proportion of children reporting adverse events was similar between the treatment group vs. placebo. Proportion of patients with serious adverse events and AEs leading to treatment discontinuation was low at 3% and 1% respectively. Teva continues to study the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety.
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