Regulatory Decision Summary for NUCALA
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.
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What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization for NUCALA (mepolizumab) as add-on maintenance treatment of adult patients with severe eosinophilic asthma, whose symptom are not controlled despite the high dose of inhaled corticosteroids.
Why was the decision issued?
The safety and efficacy of NUCALA were assessed in three double-blind, randomized, placebo-controlled trials in patients with severe asthma on currently available therapies. Compared to placebo, patients with this condition receiving NUCALA as add-on asthma treatment at the dose of 100 mg administered once every 4 weeks by subcutaneous injection, had fewer asthma exacerbations requiring hospitalisation.
NUCALA is not used to treat other eosinophilic conditions, acute bronchospasm or status asthmaticus.
NUCALA is supplied as lyophilized powder in a 100 mg single-dose vial for reconstitution. The recommended dose of NUCALA is 100 mg administered once every 4 weeks by subcutaneous injection.
The most common adverse reactions of NUCALA include headache, injections site reaction, back pain and fatigue. Hypersensitivity reactions can occur after the administration of NUCALA. In overall, the Benefit/Risk of NUCALA is considered acceptable for the above authorized indication. In order to ensure that this benefit continues to outweigh any risk after authorization, Health Canada has required several post-approval activities to be carried out and a Risk Management Plan.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| NUCALA | 02449781 | GLAXOSMITHKLINE INC | MEPOLIZUMAB 100 MG / VIAL |