Regulatory Decision Summary for Kevzara

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.


Product type:

Drug

Medicinal ingredient(s):

sarilumab

Therapeutic area:

interleukin-6 (IL-6) receptor antagonist

Type of submission:

New Drug Submission

Control number:

191745
What was the purpose of this submission?

 

The purpose of this New Drug Submission (NDS) was to seek market authorization for Kevzara in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

 

Why was the decision issued?

 

The benefit/risk ratio of Kevzara (sarilumab) indicated in the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is considered to be acceptable based on the following reasons:

Benefits
The efficacy of treatment with Kevzara was demonstrated in clinical studies as follows:

  • TARGET and MOBILITY (Part B), achieved the co-primary endpoints consisting of improvement in signs and symptoms of RA as measured by ACR20 response at Week 24;
  • improvement in physical function as measured by the change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score at Weeks 12 and 16; and
  • for the MOBILITY Part B study only, inhibition of progression of structural damage as measured by the change from baseline in van der Heijde-modified Total Sharp Score (mTSS) at Week 52.

Risks
The reported safety profile of sarilumab is in line with that of other biological products authorized for treatment of Rheumatoid Arthritis.

For more information on Health Canadas decision, please view the Summary Basis of Decision.

 

Decision issued

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