Chugai Pharmaceutical Co, Ltd and F Hoffmann-La Roche Ltd announced that RoACTEMRA, the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, filed with the European Medicines Evaluation Agency (EMEA) in November 2007, received approval as a treatment to improve symptoms of rheumatoid arthritis (RA).
Based on the co-development and co-promotion agreement between Chugai and Roche, Chugai will co-promote RoACTEMRA in UK, France and Germany, where its wholly-owned subsidiary Chugai Pharma Marketing Ltd has its marketing bases.
The main symptoms of RA are multiple joint inflammation and progressive joint damage, and it is reported that millions of patients suffer from RA in EU. RoACTEMRA, the first antibody drug (humanized monoclonal antibody) originating from Japan, was created by Chugai in collaboration with Osaka University, utilizing genetic recombinant technology to produce a monoclonal antibody against the anti-IL6 receptor. It works by inhibiting biological activity of IL-6 through competitively blocking the binding of IL-6 to its receptor.
Outside of Japan, five phase-III clinical trials, including extension studies in RA are going on in 40 countries involving more than 4,000 patients worldwide under co-development between Chugai and Roche. The approval was based on results and extension studies from four out of five of these trials, and the interim analysis of the remaining ongoing trial.
In Japan, 200mg preparation of Actemra was launched in June 2005 by Chugai for Castleman's disease, following approval in April, the same year. Subsequently, it was approved for the additional indications of RA (including prevention of structural damage of joints), polyarticular-course juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis in April 2008. 80mg and 400mg preparations were launched additionally in June 2008.
Chugai focuses on bone and joint diseases area as one of the strategic domains, and is committed to contribute to the treatment by providing new therapeutic options for medical professionals and patients.
The approval in the EU follows earlier approvals for the product in several countries, including Switzerland and India.