Regulatory Decision Summary for Emgality

Migraine is a major cause of disability in Canada and around the world. Emgality (galcanezumab injection) was evaluated in three pivotal phase 3 trials in patients having episodic and chronic migraine. In the episodic migraine studies (CGAG, EVOLVE-1 and CGAH, EVOLVE-2), there was a statistically significantly greater reduction in the mean Migraine Headache Days (MHD) from baseline for Emgality compared to placebo in both EVOLVE-1 (-1.9 days) and EVOLVE-2 (-2.0 days); both doses (120 mg and 240 mg) provided a similar change (~1.9 days) in the primary endpoint. In the chronic migraine study (CGAI, REGAIN), the reduction in mean MHD was comparable (-2 days) at the 120 mg and 240 mg doses.

Emgality demonstrated a statistically significant and clinically meaningful difference in the reduction of monthly MHD against placebo. A 240 mg loading dose followed by 120 mg monthly maintenance is recommended.

The frequency of adverse events was roughly balanced across the different treatment groups in the clinical studies. The most common adverse events were injection site reactions, pruritus, urticarial, constipation, nasopharyngitis and vertigo. The safety profile of Emgality is acceptable for the authorized indication. Some uncertainty remains with regard to the safety and efficacy of Emgality for geriatrics, pediatrics, pregnant and breastfeeding patients, among others. These limitations of data have been mitigated through labelling in the product monograph.

The overall benefit/risk profile is considered favourable for Emgality when used for prevention of migraine in adults 18-65 years of age who experience at least 4 migraine days per month. With the addition of Emgality to the available treatment options for Canadians, patients and healthcare practitioners will have additional choices when considering management strategies for migraine.

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