Ajovy superior to placebo at 12 weeks for episodic migraine in young people

Ajovy offers “significant efficacy” compared with placebo to address episodic migraine in children and adolescents, according to topline results from the phase 3 SPACE study.

According to a release from Teva, the multicenter, randomized, double-blind clinical trial of Ajovy (fremanezumab), which included 235 participants aged 6 to 17 years, met its primary endpoint of “superior efficacy” over a 12-week treatment interval. In addition, Ajovy’s safety profile was comparable with previous studies in adult volunteers, with no new safety signals observed.

The novel therapeutic, initially indicated for preventive migraine relief in adults with at least 4 migraine days per month, is available in two doses, a once-per-month 225 mg subcutaneous injection as well as a 675 mg, three-times-per-year subcutaneous injection. It is also available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or pre-filled pen that can be administered by a health care professional, caregiver or the patient themselves.

"The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine who are greatly impacted by this debilitating disease,” Eric A. Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva, said in the release. “I am pleased to see that Ajovy is continuing to demonstrate its efficacy and safety in different migraine populations, including pediatric patients.”

Teva additionally said in the release that a full data set from SPACE will be presented at a meeting yet to be determined later this year.