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 submission sought authorization for the use of Xolair (omalizumab) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP).
After evaluation of the submitted data package, Health Canada authorized the following indication: Add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by intranasal corticosteroids alone.
Why was the decision issued?
- Chronic rhinosinusitis with nasal polyps (CRSwNP) is a persistent condition with substantial impacts on quality of life. Standard treatment with intranasal corticosteroids may be insufficient in some patients, and patients qualifying for nasal polypectomy may experience recurrence of polyps.
- Authorization was based on two Phase III randomized, double-blind, placebo-controlled studies in patients with nasal polyps that included a total of 265 patients (131 placebo, 134 omalizumab). Patients received dosing based on baseline body weight and serum IgE, with doses ranging from 150 mg every 4 weeks to 600 mg every 2 weeks.
- The co-primary efficacy endpoints were change from baseline in (1) nasal congestion score (NCS) and (2) nasal polyp score (NPS). Both studies showed a significant difference in treatment with omalizumab compared to placebo as add-on to daily intranasal corticosteroids for these endpoints.
- The most common adverse events that occurred more commonly in patients treated with omalizumab than placebo were headache (8.1%) and injection site reactions (5.2%). The safety profile demonstrated in the two pivotal studies for patients treated with omalizumab for 24 weeks was consistent with the established profile of the drug.
- The recommended dose of Xolair (omalizumab) for the indication of CRSwNP is based on patient body weight and pre-treatment serum IgE. View the PM for details.
- Limitations to the data included the lack of long-term data (beyond 24 weeks) and a low proportion of clinical trial patients of non-white race.
- Based on the data submitted in support of the indication of add-on treatment with intranasal corticosteroids, the benefit-risk profile for the use of Xolair (omalizumab) in CRSwNP is considered favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations