Kevzara (Sarilumab) Approved in Canada for RA Save

Regeneron and Sanofi announced today that Health Canada has approved Kevzara (sarilumab), its interleukin-6 (IL-6) receptor monoclonal antibody, for use in moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs.

This becomes the first competitor for tocilizumab (Actemra) and it is presumed that other IL-6 inhibitors will populate the marketplace in the next few years.

Sarilumab was approved based on data from the global SARIL-RA clinical trials with approximately 2,900 RA patients showing it effectively reducies signs and symptoms, and improves quailty of life and radiographic progression in RA.

Kevzara many be used as monotherapy or in combination with methotrexate or other traditional DMARDs. The recommended dose of Kevzara is 200 mg once every two weeks given as a subcutaneous injection; dosage can be reduced from 200 mg to 150 mg once every two weeks to help manage certain laboratory abnormalities.

The safety profile is similar to that seen with tocilizumab. 

This same drug has been in front of the FDA but hit a snag when the FDA noted a manufacturing issue. The resubmission of the sarilumab BLA is expected in the first quarter of 2017 and the company is anticipating an action date in the second quarter of 2017.

The European Medicines Agency is also reviewing an application for sarilumab (since July 2016) and expects to make a decision later this year.