Regulatory Decision Summary for Fasenra

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.