Roche announces Health Canada approval for ACTEMRA to treat RA

May 4 2010

First monoclonal antibody to target the IL-6 inhibitor approved based on largest clinical development program in rheumatoid arthritis to date

Roche today announced that Health Canada has approved ACTEMRA(TM) (tocilizumab) to treat patients with rheumatoid arthritis (RA), a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications, such as fatigue and anemia.

ACTEMRA is indicated for reducing signs and symptoms in adult patients with moderately to severely active RA who have inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs) and/or tumour necrosis factor (TNF) antagonists.

General use of ACTEMRA in DMARD-inadequate responder (IR) patients is not recommended at this time. Physicians may consider the use of ACTEMRA in the DMARD-IR population on a case by case basis dependent on disease and patient characteristics, experience with the drug, and the benefits and risks of ACTEMRA as compared to other therapeutic options available.(1)

There are several key cytokines, or proteins, involved in the inflammatory process, including IL-6. Research shows that IL-6 levels are elevated in patients with RA. ACTEMRA is the first medication designed to specifically inhibit the biological activity of IL-6.

Despite the treatment options currently available, many people with RA do not respond adequately in order to achieve remission, subsequently resulting in disease progression and unnecessary pain and suffering.

"The approval of ACTEMRA in Canada allows for a new way of treating RA and offers another treatment option," says Dr. Janet Pope, a rheumatologist and Professor of Medicine at the University of Western Ontario, London, Ontario. "Results in ACTEMRA clinical trials have shown long-lasting relief from symptoms and stopping progression of the disease - and remission in many people - which is truly the ultimate goal of treatment for RA."

"Since I was first diagnosed with RA at the age of 42, my quality of life quickly deteriorated and I was living with constant pain and overwhelming exhaustion," said Ian McKay. "Being unable to perform daily functions that come so naturally to most of us was very taxing on my family. Today, with ACTEMRA, I have my energy back, and I am living life to its fullest."

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.