Teva Pharmaceutical Industries has reported positive outcomes from its multicentre Phase III SPACE trial of Ajovy (fremanezumab) as a preventive treatment for episodic migraine in young individuals aged six to 17 years.
The double-blind, parallel-group, randomised, placebo-controlled trial demonstrated a statistically significant reduction in migraine frequency over 12 weeks compared to placebo, with a safety profile in line with that observed in adults.
It involved 237 subjects aged six to 17 years with episodic migraine.
These young subjects had been diagnosed with migraine for at least six months and experienced fewer than 14 headache days per month. The study also conducted subgroup analyses by age and sex.
Key findings showed that fremanezumab led to a significant reduction in monthly migraine days (MMD) and monthly headache days (MHD) compared to placebo.
Additionally, a substantially higher percentage of paediatric subjects achieved a 50% response rate with the therapy compared to those on placebo. Consistent benefits were observed across different age groups and between girls and boys.
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By GlobalDataIn terms of safety, the therapy was well tolerated without any safety signals reported.
The subjects’ proportion reporting one or more adverse events was found to be comparable between the treatment and placebo groups, with low serious adverse events and discontinuations due to adverse events.
Teva Pharmaceuticals global R&D executive vice-president and chief medical officer Eric Hughes said: “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.
“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.”
The company is planning to further investigate the effects and long-term safety profile of the therapy in children with chronic migraine.
Last month, the company reported data from a Phase III trial of its candidate, TEV-‘749 (olanzapine), for schizophrenia treatment.
