Health Canada approves subcutaneous Actemra (tocilizumab) for use in adult patients living with moderately to severely active rheumatoid arthritis

CADTH

Roche today announced that Health Canada has approved a subcutaneous (SC) formulation of ACTEMRA (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF) antagonists. Like the intravenous (IV) formulation, the SC formulation can be used both as a single-agent therapy, or monotherapy, and in combination with methotrexate or other non-biologic DMARDs.

The ACTEMRA pre-filled syringe (PFS) injection formulation will be available in Canadain June.ACTEMRA SC is the first and only humanized interleukin-6 receptor-antagonist monoclonal antibody approved by Health Canada for both subcutaneous and intravenous administration in rheumatoid arthritis. The subcutaneous formulation has comparable efficacy and safety to the IV formulation.3,4 Under guidance of a healthcare practitioner and after appropriate training, adult patients or the patient's caregiver will be able to administer ACTEMRA SC via a pre-filled syringe at home.

For more details, go to: 
http://www.newswire.ca/en/story/1351851/health-canada-approves-actemra-tocilizumab-subcutaneous-for-...

Michael Wonder

Posted by:

Michael Wonder

Posted in: