Health Canada's approval of ACTEMRA was based on results from the largest clinical program undertaken by an RA biologic manufacturer including five multi-national Phase III studies which demonstrated that treatment with ACTEMRA - alone or combination with methotrexate (MTX) or other DMARDs - significantly reduced RA signs and symptoms, compared with current DMARDs alone, as shown by primary and secondary endpoints including ACR and DAS scores. These benefits were seen regardless of previous therapy or disease severity. ACTEMRA is approved for the treatment of RA in the United States, the European Union, and several other countries including Australia, Switzerland, Brazil and India.

Approved for adult patients with RA who have had an inadequate response to one or more DMARDS and/or TNF antagonists, the recommended starting dose of ACTEMRA is every four weeks as an intravenous infusion over one hour to be administered in infusion clinics. It may be used alone or in combination with MTX or other DMARDs at the following dose: 4 mg/kg followed by an increase to 8 mg/kg based on clinical response.

"This announcement is great news for people living with rheumatoid arthritis," said Cheryl Koehn, President of Arthritis Consumer Experts. "Health Canada's approval of tocilizumab will add to the RA treatment arsenal, which is important given that there continues to be significant unmet need in the treatment of this disease. I am hopeful that the Common Drug Review process and subsequent provincial formulary reviews will be completed in a timely manner, and that reimbursement coverage will be made available for tocilizumab as part of the full range of Health Canada-approved arthritis medications."

Provincial formulary coverage of ACTEMRA in Canada will be sought. In the meantime, people who are prescribed this medication by their rheumatologists may be able to access the medication through Jointeffort, part of the Roche Patient Assistance Program (RPAP). Jointeffort program case workers will navigate private insurance plans to determine an individual's coverage.

Source: ROCHE