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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What was the purpose of this submission?
The purpose of this Supplement to New Drug Submission (SNDS) was to gain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Cosentyx, submitted by Novartis Pharmaceuticals Canada Inc.
This Supplement to a New Drug Submission was filed to gain market authorization for the new subcutaneous dosage forms for Cosentyx: a 300 mg/2 mL solution for injection in pre-filled syringe (PFS) and a 300 mg/2 mL solution for injection in pre-filled autoinjector (AI), in order to allow administration of a 300 mg dose in a single 2 mL injection instead of two injections, with the aim of improving patients’ convenience and treatment compliance. There is no change to the drug formulation or the authorized indications or dosing regimens.
Why was the decision issued?
- Authorization for the new subcutaneous dosage forms was based on:
- A Phase I study (Study A2107) of six different injection methods, including the approved 1 mL PFS and 1 mL AI in healthy subjects.
- Phase III studies in psoriasis patients (Study A2323, Study A2325) of 2 mL PFS and 2 mL AI, respectively, in moderate to severe plaque psoriasis patients.
- Plaque psoriasis is a chronic inflammatory skin condition, usually characterized by pruritic erythematous patches, flaking, and scales. Psoriasis has a broad impact on patients that extends beyond the cosmetic or physical aspects.
- The recommended dose of secukinumab in adult patients is 300 mg for moderate to severe plaque psoriasis. Other indications for which Cosentyx is authorized in Canada use doses from 75 mg to 300 mg. The currently registered dosage forms of secukinumab are:
- 75 mg/0.5 mL solution for injection
- 150 mg/1 mL solution for injection
- The efficacy and safety profile of Cosentyx in both Phase 3 studies in adults with plaque psoriasis were consistent with the established profiles in this patient population. There was no difference in efficacy and safety profiles associated with the use of a single 2 mL injection with the PFS or AI devices as compared to two 1 mL injections with the currently-marketed PFS device.
- An updated Risk Management Plan (RMP) for Cosentyx was reviewed by Health Canada and considered acceptable.
- The chemistry and manufacturing information submitted for Cosentyx has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.
- Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
- The overall, the benefit-harm-uncertainty profile is favourable for Cosentyx and the new 2 mL presentations. A Notice of Compliance (NOC) was issued.
For further details about Cosentyx, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| COSENTYX | 02529653 | NOVARTIS PHARMACEUTICALS CANADA INC | SECUKINUMAB 300 MG / 2 ML |
| COSENTYX | 02529661 | NOVARTIS PHARMACEUTICALS CANADA INC | SECUKINUMAB 300 MG / 2 ML |