Regulatory Decision Summary for Emgality

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

(galcanezumab)

Therapeutic area:

Antimigraine preparations

Type of submission:

Supplement to a New Drug Submission

Control number:

232324
What was the purpose of this submission?

 

The purpose of this submission is to seek market authorization for Emgality (galcanezumab injection) for the prevention of attacks throughout a cluster period in adults with episodic cluster headache.

At the time of this submission, Emgality was authorised in Canada for the prevention of migraine in adults who have at least 4 migraine days per month.

 

Why was the decision issued?

 

Cluster headache is disabling and is considered the most severe form of primary headaches. Efficacy of Emgality (galcanezumab) was evaluated in one phase 3 multicentre, randomized, 8-week duration, double-blind, placebo-controlled trial in adult patients with episodic cluster headache, which showed a reduction of headache attacks in the galcanezumab-treated patients compared with the placebo-treated patients.

In consideration of the nature of episodic cluster headache, clinically, there is value in the use of Emgality for adult patients with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines.

The frequency of adverse events was consistent across the different treatment groups. The most commonly reported adverse events were injection site pain, redness, bruising, swelling, induration, pruritus, constipation, and vertigo. The safety profile of Emgality is acceptable for the sought indication.

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

The overall benefit/risk profile is considered favourable for Emgality when used for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.