Regulatory Decision Summary for Ajovy

Migraine is a major cause of disability in Canada and around the world. Ajovy (fremanezumab) was evaluated in two phase 3 multicentre, randomized, 3-months duration, double-blind, placebo-controlled trials in patients having episodic and chronic migraine.

In the episodic migraine study (Study 1), for the primary endpoint, the mean change from baseline in the monthly average number of migraine days were -2.2, -3.4, and -3.7 days for the placebo group, fremanezumab 675 mg quarterly group, and fremanezumab 225 mg monthly group, respectively. The adjusted mean treatment difference was -1.2 days between fremanezumab 675 mg quarterly and the placebo group, and the difference was -1.4 between fremanezumab 225 mg monthly group and the placebo group, both p < 0.0001. Key secondary efficacy endpoints in favour of the primary endpoint.

In the chronic migraine study (Study 2), for the primary endpoint, the mean change from baseline in the monthly average number of headache days of at least moderate severity were -2.5, -4.3 and -4.6 days for the placebo group, fremanezumab 675 mg quarterly group, and fremanezumab 675/225/225 mg monthly group, respectively. The adjusted mean treatment difference was -1.8 days between fremanezumab 675 mg quarterly group and the placebo group, and the difference was -2.1 between fremanezumab 675/225/225 mg monthly group and the placebo group, both with a p-value < 0.0001.

Key secondary efficacy endpoints in favour of the primary endpoint.

The short duration (3 months) of pivotal clinical trials limits claims for prevention of migraine with sustained efficacy. Therefore, the benefit of Ajovy should be assessed within 3 months after initiation of treatment. The decision to continue treatment should be taken on an individual patient basis. The need to continue treatment with Ajovy should be re-evaluated regularly.

The frequency of adverse events was consistent across the different treatment groups. The most commonly reported adverse events were injection site reactions, pruritus, urticaria, induration, and erythema. The safety profile of Ajovy is acceptable for the sought indication.

Uncertainty remains with regard to the safety and efficacy of Ajovy for geriatrics, pediatrics, pregnant and breastfeeding patients, among others. These limitations are described and mitigated through labelling.

The overall benefit/risk profile is considered favourable for Ajovy when used for prevention of migraine in adults 18-65 years of age who experience at least 4 migraine days per month.

For more information on Health Canadas decision, please view the Summary Basis of Decision.