The company claims that Actemra is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
The company said that Actemra has been studied in five multi-national phase III studies, involving more than 4,000 patients for an indication in RA to date. The studies showed that Actemra, alone or in combination with methotrexate or other DMARDs, reduced RA signs and symptoms compared with DMARDs alone. The approval is based on data from those trials.
Reportedly, Actemra is approved for once-a-month intravenous administration in doctors’ offices, hospitals and infusion centers, and may be used alone or in combination with methotrexate or other DMARDs in the following dosage: Actemra 4mg/kg is the recommended starting dose when used in combination with DMARDs or as a monotherapy in patients who have had an inadequate response to one or more TNF antagonists; the dose may then be increased to 8mg/kg based on clinical response.
Actemra has been approved with a Risk Evaluation and Mitigation Strategy (REMS) that includes a medication guide, communication plan and timetable for submission of assessments. The plan was developed to provide support and education to patients and healthcare providers. Actemra will be available around January 18, 2010.
Hal Barron, executive vice president of global development and chief medical officer at Roche and Genentech, said: “The FDA approval of Actemra marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease.
“We are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy and are committed to comprehensively characterising both the clinical benefit and the safety of Actemra in earlier lines of therapy through our pharmacovigilance program, including the risk management program, and ongoing clinical and post-marketing studies globally.”