Regulatory Decision Summary for CINQAIR
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 Cinqair (reslizumab), as add-on maintenance treatment of adult and adolescent patients (12 years of age and above) with severe eosinophilic asthma, whose symptom are not controlled despite the medium-to- high dose of inhaled corticosteroids.
Why was the decision issued?
Benefit
The clinical development program with reslizumab indicated that the patients who benefit the most were those who experienced the highest frequency of exacerbations and had the highest levels of blood eosinophils at study entry, which is fully consistent with the mechanism of action of reslizumab.
Reslizumab as an add-on maintenance treatment of adult patients with severe eosinophilic asthma demonstrated a clinically meaningful effect in reduction of the number of asthma exacerbations.
Risks
Due to the limited clinical data in pediatric patients 12 to 17 years of age, it was difficult to draw any conclusion on whether efficacy and safety profile was comparable to adults. Therefore, the indication sought is limited to adult patients only.
Long-term safety of treatment is limited and will be further assessed by evaluating Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRER) for Cinqair, Drug Events as per the Pharmacovigilance Plan, and all ongoing clinical trials with reslizumab.
Based on data provided, there was no apparent increased risk of malignancy, infections, serious cardiac, vascular and ischaemic events.
The overall risk of systemic allergic and non-allergic reactions with reslizumab and the immunogenic potential of reslizumab appeared to be low.
The risk of anaphylactic reactions is present and outlined in the black box of Canadian Product Monograph (CPM).
There is the limited safety data for elderly patients, so it was difficult to draw any conclusion on whether safety profile is comparable to younger patients.
Animal studies did not indicate reproductive toxicity. However, there was limited data from the use of reslizumab in pregnant women to draw any conclusions.
Company established pharmacovigilance procedures for pregnancy reporting, which will be complemented by proactive identification of pregnancies through Cinqairs "Teva Support Solution". The program is outlined in CPM and RMP.
Cinqair is not used to treat other eosinophilic conditions, acute bronchospasm or status asthmaticus.
Benefit/Risk conclusion
Based on the above and as labelled, the overall benefit/risk of Cinqair (reslizumab) is considered favourable.
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 |
|---|---|---|---|
| CINQAIR | 02456419 | TEVA CANADA LIMITED | RESLIZUMAB 10 MG / ML |