Contact: Office of Regulatory Affairs, Biologics and Genetic Therapies Directorate

Active ingredient(s)
Reslizumab
Therapeutic area
Anti-interleukin - 5 (IL-5) antibody
Type of submission
New Drug Submission
Control number
185873
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 Cinqair's "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.

Decision issued

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

Date of decision

2016-07-20

Additional information

Manufacturer
Teva Canada Limited
Drug Identification Number(s) issued
02456419
Prescription status
Cinqair is available by prescription only
Date filed
2015-07-03


http://www.hc-sc.gc.ca/dhp-mps/prodp...185873-eng.php