Regulatory Decision Summary for Fasenra

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:


Medicinal ingredient(s):

Benralizumab injection

Therapeutic area:


Type of submission:

New Drug Submission

Control number:

What was the purpose of this submission?


This New Drug Submission was filed to seek market authorization for Fasenra (benralizumab injection) as a medicine used, in addition to other asthma medicines, for maintenance treatment of adult patients with severe eosinophilic asthma, whose asthma is not controlled with their current asthma medicines. Eosinophils are a type of white blood cell that may contribute to asthma by causing inflammation in the lungs. By attaching to the eosinophils, Fasenra reduces the number of eosinophils in the blood and lungs


Why was the decision issued?


Severe asthma affects 5-10% of asthmatics, but this small group of people with severe asthma is often at greatest health risk.

In two similar large-scale (>1500 patients total), long-term (48-56 week duration) clinical trials, Fasenra decreased the number of annual asthma attacks in patients with high amounts of blood eosinophils by 51% and 28% compared to placebo. Additionally, Fasenra decreased the risk of patients having an asthma attack by 40% and 27% compared to placebo. Fasenra also helped improve breathing, and decreased symptoms related to asthma. In patients with low amounts of blood eosinophils, Fasenra decreased the number of annual asthma attacks by 17% and 40% compared to placebo, and showed improvement in breathing, and decreased symptoms.

A third clinical trial was conducted over 28 weeks in approximately 150 patients who were already taking oral corticosteroids to reduce their asthma symptoms. The results showed that the daily oral corticosteroid dose was reduced by 75% in patients receiving Fasenra compared to 25% in patients receiving placebo.

There was no notable increase in commonly reported side-effects in patients treated with Fasenra compared to placebo. Fasenra was generally well-tolerated.

Overall, based on the data evaluated as part of this submission, Health Canada considered there to be enough evidence to conclude a favourable benefit-risk profile for Fasenra as an add-on maintenance treatment of adults with severe eosinophilic asthma.


Decision issued

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