Regulatory Decision Summary for Nucala
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 was for the authorization of Nucala (mepolizumab) as 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?
Authorization was based on a Phase 3 randomized, double-blind, placebo-controlled trial (# 205687, “SYNAPSE”). Patients (n = 407) with CRSwNP received either mepolizumab (n = 206) or placebo (n = 201) at a dose of 100 mg administered subcutaneously every 4 weeks for 52 weeks.
The co-primary endpoints were endoscopic nasal polyp score (NPS) and nasal obstruction visual analogue scale (VAS) score at Week 52. There was a statistically significant benefit to mepolizumab over placebo for the co-primary endpoints as well as a number of secondary endpoints.
The most common adverse events that occurred in at least 5% of patients and more commonly in patients treated with mepolizumab than placebo were nasopharyngitis, oropharyngeal pain and arthralgia. The safety profile for adult patients with CRSwNP treated with mepolizumab as demonstrated in the 52-week pivotal study is consistent with the previously established risk profile for mepolizumab.
The recommended dose of the drug is 100 mg administered subcutaneously every 4 weeks, as add-on to daily intranasal corticosteroids. View the Product Monograph for details.
CRSwNP presents a chronic and substantial impact on quality of life and is often inadequately treated by or refractive to established therapies. Data from this submission indicated a meaningful treatment benefit to mepolizumab as add-on to daily intranasal corticosteroids compared to placebo after 52 weeks of treatment. The safety profile was consistent with that of mepolizumab in patients with other eosinophilic conditions and risks are deemed to be adequately addressed with labelling. As such, the benefit-risk profile for the use of mepolizumab as add-on therapy in adults with CRSwNP is considered favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations