Regulatory Decision Summary for Tremfya / Tremfya One-Press / Tremfya I.V.

The purpose of the submission is to seek marketing authorisation for a new indication for the treatment of adult patients with moderately to severely active Crohn’s disease (CD), and three new presentations associated with the new indication. The new presentations included in this submission are an intravenous Infusion (IV) in a single use vial (200 mg/20 mL [10 mg/mL]), and a subcutaneous injection in a pre-filled syringe or single dose pen (both presentations 200 mg/2mL [100 mg/mL]). The dosage strength for the subcutaneous routes of administration is the same strength that has been previously approved. The new IV presentation is the recommended dose for the induction phase of dosing for Crohn’s Disease. The new subcutaneous dose presentations are recommended for maintenance dosage.

There is a clear unmet medical need for additional efficacious therapeutic options in Crohn’s Disease with a favorable safety profile for patients with an inadequate response to or intolerance to conventional or advanced therapies.

Overall, the benefit-harm-uncertainty profile was favourable for Tremfya / Tremfya One-Press / Tremfya I.V. for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

An updated Risk Management Plan (RMP) for Tremfya / Tremfya One-Press / Tremfya I.V. was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Tremfya / Tremfya One-Press / Tremfya I.V. has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications. Adequate process validation and stability information is provided to support approval of the proposed 200 mg/2 mL prefilled syringe/pen and 200 mg/20 mL vial presentations.

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

For further details about Tremfya / Tremfya One-Press / Tremfya I.V., please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.