Hoffmann-La Roche Inc (NUTLEY, New Jersey) announced that the Arthritis Advisory Committee of the US FDA in a 10-1 vote recommended approval of Actemra^® (tocilizumab), a novel interleukin-6 (IL-6) receptor-inhibiting humanized monoclonal antibody, for reducing the signs and symptoms in adults with moderate-to-severe rheumatoid arthritis (RA).

The committee's vote was made based on results from five phase III clinical trials, all of which met their primary endpoints. The clinical development program was designed to evaluate the effects of Actemra, administered by infusion, on signs and symptoms of RA, physical function, progression of structural damage, and health-related quality of life. Of the five studies, three were conducted in patients with inadequate response to disease modifying antirheumatic drugs (DMARDs), one trial was conducted in patients who failed anti-TNF therapy, and one monotherapy study compared Actemra to methotrexate (MTX). Study results demonstrated that treatment with the drug, alone or in combination with MTX or other DMARDs significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with current DMARDs.

The clinical development program conducted by Roche enrolled >4000 patients in 41 countries, including the US. The LITHE trial evaluating the drug in RA is an ongoing 2-year study and is expected to report complete data (interim analysis has been reported) evaluating the effects of Actemra on the inhibition of structural joint damage in 2009. The drug is also awaiting approval in Europe.

Actemra is part of a codevelopment agreement with Tokyo-based Chugai Pharmaceutical Co, a member of the Roche group. The drug was created by Chugai in collaboration with Osaka University. In June 2005, the drug was launched by Chugai in Japan as an orphan drug for Castleman's disease; in April 2008, additional indications for RA (including prevention of structural damage of joints), juvenile idiopathic arthritis, and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

The serious adverse events reported in Actemra clinical trials include serious infections, diverticular perforations, and hypersensitivity reactions including anaphylaxis. The most common adverse events reported in clinical trials were upper respiratory tract infection, nasopharyngitis, headache, and hypertension.