▎WuXiEdited by Kant Content Team

December 4,TevaAnnounced positive data from its Phase 3 SPACE study, which evaluated Ajovy (fremanezumab)Prevention of Episodic Migraine in Pediatric Patients Aged 6 to 17 YearsEfficacy and safety.Ajovy is a humanized CGRP monoclonal antibody.The trial results showed that, compared with placebo, Ajovy was statistically significantly superior to placebo in efficacy within 12 weeks.Significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) over a 12-week period., its good safety profile is consistent with the results observed in the adult population.

Migraine is one of the common diseases in neurology. Although it is not a fatal disease, patients suffer greatly and their lives are seriously affected during an attack. Besides being common in adults,Migraine is also common in children and adolescents.EstimateThe overall prevalence rate is 7.7%.[2]Migraine can have a significant impact on children and adolescents, leading to school absences, impaired academic performance, and missed social activities. Over the past 30 years, the incidence of migraine in children has increased, but there remains a lack of innovation in the treatment of pediatric migraines.

Ajovy is a humanized CGRP monoclonal antibody that was approved by the U.S. FDA in 2018.Approved for Marketing, asPreventive Therapy for Adult MigraineThe CGRP signaling pathway is a popular target for migraine treatment. Globally, several antibody therapies targeting the CGRP receptor or CGRP itself have been approved for the preventive treatment of migraines. Ajovy is one of them.

According to the press release from Teva Pharmaceutical Industries Ltd., Ajovy is suitable for the preventive treatment of migraine in adults who experience at least four migraine days per month. The product offers two dosing options: a 225 mg subcutaneous injection administered once a month (monthly dosing), or a 675 mg subcutaneous injection administered three times every three months (quarterly dosing). Ajovy can be administered either by healthcare professionals or by patients or caregivers at home.

SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compared the efficacy, safety, and tolerability of subcutaneous fremanezumab as a preventive treatment for episodic migraine in 237 pediatric and adolescent patients aged 6 to 17 years over a 12-week period. Participants were diagnosed with migraine for 6 months or longer and experienced fewer than 14 headache days per month.

SPACE study data show that, over a period of more than three months, fremanezumab achieved:

• Compared with placebo, the number of monthly migraine days (MMD) was significantly reduced (-2.5 vs -1.4);

• Compared with placebo, the number of monthly headache days (MHD) was significantly reduced (-2.6 vs -1.5).)；

• Compared with placebo, the number of children achieving a 50% relief rate significantly increased (47.2% vs 27.0%);

• Fremanezumab also demonstrated good safety and was well-tolerated, with no safety signals.

Teva Pharmaceutical Industries Ltd. said it will continue to study the effects of fremanezumab on children and adolescents with chronic migraine, as well as its long-term safety.

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