Regulatory Decision Summary for Cosentyx

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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Type of Submission:

Supplement to a New Drug Submission

Decision Issued:

Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations

What was the purpose of this submission?

The purpose of this Supplement to a New Drug Submission (SNDS), filed by Novartis Pharmaceuticals Canada Inc., was to seek market authorization for Cosentyx (secukinumab) for the treatment of adult patients with moderate to severe hidradenitis suppurativa.

The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.

Why was the decision issued?

Hidradenitis suppurativa (HS) is a painful, chronic, recurrent and debilitating inflammatory skin condition of the pilosebaceous follicle with an underlying immune system imbalance that occurs in genetically predisposed individuals. HS typically presents with painful, deep, inflammatory lesions, mostly inflammatory nodules and abscesses, which progressively scar and suppurate and lead to malodorous discharge in the apocrine gland-bearing parts of the body. HS is a profoundly debilitating disease with a highly negative impact on QoL and devastating psychological effects. A prevalence of approximately 0.1% to 1% is accepted by the scientific community; however, it has been estimated that up to 3.8% of the Canadian population has HS, as a lack of awareness of HS has been suggested to contribute to initial misdiagnoses.

A Notice of Non-Compliance (NON) was issued by Health Canada due to concerns regarding the robustness of the statistical analysis of the pivotal study. In response to the NON, the sponsor submitted rationales and additional analyses that addressed the concerns raised by Health Canada.

The benefits of Cosentyx have been demonstrated by the replicate phase 3 multicentre, randomized, double-blind, placebo-controlled studies (CAIN457M2301 [SUNSHINE] and CAIN457M2302 [SUNRISE]) designed to evaluate the efficacy and safety of secukinumab in subjects with moderate-to-severe HS.

Study M2301 and study M2302 demonstrated that a greater proportion of subjects receiving Cosentyx 300 mg than placebo achieved the clinically relevant endpoint of HiSCR50 at Week 16, defined as at least a 50% decrease in abscesses (fluctuant, with or without drainage, tender or painful) and inflammatory nodules (tender, erythematous, pyogenic granulomatous lesions) with no increase in the number of abscesses or the number of draining fistulae (sinus tracts, with communications to skin surface, draining purulent fluid) from baseline. Additional benefits in favour of Cosentyx were observed in patient’s reported global assessment of skin pain using a numerical rating scale (NRS) in subjects who entered the studies with a baseline score of 3 or greater.

The incidence of treatment-emergent adverse events (TEAEs) were generally consistent when comparing secukinumab to placebo, with few serious adverse events (AE), AEs of special interest, and discontinuations due to AEs reported. TEAE were generally mild-to-moderate intensity, were non-serious, and did not require treatment discontinuation. The most frequently reported TEAE were headache, nasopharyngitis, and fatigue; however, the incidence were relatively low. Serious AEs were generally reported as single incidences with no observable trend suggestive of a greater risk of serious AEs in subjects receiving secukinumab than placebo. The safety profile of Cosentyx in adults with moderate to severe HS appears generally consistent with that previously established for adults treated with secukinumab for other authorized indications. Identified risks are considered sufficiently mitigated by product labelling and routine pharmacovigilance activities.

An updated Risk Management Plan (RMP) for Cosentyx was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, based on the data and information evaluated as part of this assessment, the benefit-harm-uncertainty profile was favourable for Cosentyx (secukinumab) in support of an extension to the authorized indication for the treatment of adults with HS when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Cosentyx, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.

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Novartis Pharmaceuticals Canada Inc.

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Prescription Status:

Available by prescription only

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