Regulatory Decision Summary for Actemra

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):

tocilizumab

Therapeutic area:

Antihuman interleukin-6-receptor monoclonal antibody

Type of submission:

Supplemental New Drug Submission (SNDS)

Control number:

204251
What was the purpose of this submission?

 

This Supplemental New Drug Submission (SNDS) was filed obtain market authorization for a new indication for Actemra Subcutaneous Injection (SC) for the treatment of giant cell arteritis (GCA) in adult patients. Upon review, this SNDS is authorized under the Notice of Compliance (NOC).

 

Why was the decision issued?

 

The clinical safety and efficacy data supporting the sought indication by this SNDS are derived primarily from the 52-week Phase 3 clinical trial WA28119, involving 251 patients, aged above 50 years old, with GCA who had limited treatment options. The primary endpoint of the study were the proportion of patients (responders) in sustained remission at Week 52 following induction at Week 12 in tocilizumab once weekly (QW) or once every other week (Q2W) treatment group as compared with the placebo group that underwent the 26- or 52-week prednisone taper. In combination with a 26-week prednisone taper, sustained remission was reported in 56.0% and 53.1% of patients who received tocilizumab 162 mg QW and Q2W, respectively, after 12 months of Actemra treatment. In comparison, 14.0% and 17.6% of patients who received a placebo with a 26-week, or 52-week prednisone taper, respectively, achieved sustained remission.

The safety profile of Actemra from the 52-week GCA trial, including the type and incidence of adverse events (AEs), was comparable between the Actemra -treated and placebo groups and was consistent, in overall, with the currently known safety profile of Actemra. No new safety concerns were identified. Historical comparison between GCA and rheumatoid arthritis (RA) patients who received tocilizumab administration showed a similar safety profile in general, except a higher incidence of infection/serious infection in GCA patients than in RA patients. This discrepancy has been reflected in the labelling of Actemra. Safety and efficacy of Actemra for GCA treatment beyond 12 months is unknown. The Canadian Risk Management Plan (RMP) for Actemra has been updated with the information for SC administration and is considered acceptable.

The overall benefit/risk assessment supports of the use of Actemra at a SC dose of 162 mg weekly or every other week as an alternative to corticosteroids for the treatment of GCA patients who have limited therapeutic options.

 

Decision issued

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