Regulatory Decision Summary for XOLAIR
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?
This Supplemental New Drug Submission (SNDS) was filed to extend the market authorization of XOLAIR to pediatric patients, aged 6 to <12 years, with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (ICS).
Why was the decision issued?
The safety and efficacy of XOLAIR was assessed in one 52-week, randomized, double-blind, placebo-controlled study in pediatric patients (6 to <12 years of age) with moderate to severe allergic asthma, inadequately controlled despite the use of inhaled corticosteroids (ICS) with or without other controller medication, and have a documented history of asthma exacerbation. Additional data to support the efficacy and safety of XOLAIR were provided by one supportive 28-week randomized, placebo-controlled study, and two National Institute of Allergy and Infectious Disease (NIAID)-sponsored studies. The results obtained from these clinical trials showed that treatment with XOLAIR, used as add-on therapy, reduces the rate of clinically significant asthma exacerbations in the patient population studied.
The recommended dose is 75 to 375 mg administered subcutaneously every 2 or 4 weeks. Dose (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
No overall differences were observed in the safety of XOLAIR in the pediatric population compared to the previously authorized adult and adolescent (≥12 years of age) population. Therefore, the benefit/risk ratio is considered favourable. In order to ensure that the benefit continues to outweigh any risk after authorization, Health Canada has required standard post-approval activities to be carried out as well as a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations