Health Canada Approves Actemra (tocilizumab) Subcutaneous Formulation

Roche said Canadian regulators had approved its subcutaneous (SC) formulation of Actemra (tocilizumab) to treat adults with moderately to severely active rheumatoid arthritis who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumor necrosis factor antagonists.

The SC formulation can be used alone or in combination with methotrexate or other non-biologic DMARDs, the company said. The Actemra pre-filled syringe injection formulation will enter the Canadian market in June.

Health Canada approved Actemra SC for both subcutaneous and intravenous administration in rheumatoid arthritis, and it is the first and only humanized interleukin-6 receptor-antagonist monoclonal antibody to receive such approval, Roche said.

Patients will be able to administer Actemra SC themselves at home after appropriate training and guidance. The subcutaneous formulation is comparable to the IV formulation in efficacy and safety.

"Patients who are currently prescribed a subcutaneous formulation appreciate the ease of self-injection at home, and ACTEMRA SC provides another great option for these patients." said Terri Lupton, registered nurse clinician specializing in rheumatology.

The initial dose of Actemra SC for adult patients who have had an inadequate response to one or more DMARDs and/or TNF antagonists is 162 mg given every other week. Increasing to a weekly dose is based on clinical response as a subcutaneous injection. — Kellen Owings

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