Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody seeking approval to treat rheumatoid arthritis
BASEL, Switzerland | November 21, 2007 | Roche Submits Application for FDA Approval of Actemra for the Treatment of Rheumatoid Arthritis
Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody seeking approval to treat rheumatoid arthritis
Roche announced today the submission of a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval for Actemra (tocilizumab) to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA).
“The filing for Actemra in the U.S. is an important milestone for Roche, and brings us another step closer to making this therapy available to the millions of patients in the United States who suffer from the pain and debilitating effects of rheumatoid arthritis,” said William M. Burns, CEO of the Pharmaceuticals Division at Roche.
Actemra is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA. Research suggests that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, may reduce inflammation of the joints and relieve certain systemic effects of RA.
The BLA submission to the FDA is based on results from five international Phase III studies
which demonstrated Actemra as monotherapy or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis, as measured by ACR and disease activity score (DAS) remission rates, compared with DMARD therapies alone. Furthermore, patients who had previously failed anti-tumor necrosis factor (anti-TNF) treatments also showed significant improvement in signs and symptoms of RA after treatment with Actemra.
The clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 40 countries, including the U.S. and Europe. One of these Phase III trials evaluating Actemra in RA is an ongoing two-year study and is expected to report one-year data evaluating the effect of Actemra on the inhibition of structural damage in 2008.
Roche will file a Marketing Authorisation Application (MAA) for the product with the European Medicines Agency (EMEA) in early December.
About Actemra
Actemra is the result of research collaboration by Chugai and is being co-developed globally with Chugai. Actemra is the first humanised interleukin-6 (IL-6) receptor inhibiting monoclonal antibody and represents a novel mechanism of action to treat RA, a disease with a high unmet medical need. The overall safety profile observed in the global studies of Actemra is consistent and Actemra is generally well tolerated. The serious adverse events reported in Actemra global clinical studies included serious infections and hypersensitivity reactions including a few cases of anaphylaxis. The most common adverse events reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension. Increases in liver function tests (ALT and AST) were seen in some patients. These increases were generally mild and reversible, with no hepatic injuries or any observed impact on liver function.
Roche and Chugai are collaborating on a phase III clinical development programme in RA running outside Japan, with more than 4000 patients enrolled in 40 countries including several European countries and the USA. In Japan, Chugai launched Actemra in June 2005 as a therapy for Castleman’s disease and in April 2006 filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
About Roche in rheumatoid arthritis
One of the most important drivers for growth at Roche over the next few years is expected to be the company’s emerging franchise in autoimmune diseases with rheumatoid arthritis as the first indication. Following the launch of MabThera (rituximab) there are a number of projects in development, potentially allowing Roche to build on further opportunities. MabThera is the first and only selective B-cell therapy for RA, providing a fundamentally different treatment approach by targeting B cells, one of the key players in the pathogenesis of RA. Actemra is Roche’s second novel medicine and is a humanised monoclonal antibody to the interleukin-6 (IL-6) receptor, inhibiting the activity of IL-6 , a protein that plays a major role in the RA inflammation process. Additional projects creating a rich pipeline include compounds in Phase I, II and III clinical trials. Notably, ocrelizumab, a humanised anti-CD20 antibody, has entered phase III development for RA.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at www.roche.com.
About Chugai
Chugai Pharmaceutical, specializes in prescription pharmaceuticals and based in Tokyo, is Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products.
Since the start of the strategic alliance with Roche in October 2002, Chugai is actively involved in prescription pharmaceutical R&D activities in Japan and abroad as an important member of the Roche Group. Specifically, Chugai is working to develop innovative products with global applications, focusing on the disease areas of oncology, renal disease, and bone and joint.
In Japan, Chugai’s research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and Ukima is conducting research for technology development for industrial production. Overseas, Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. Additional information is available on the Internet at www.chugai-pharm.co.jp.
SOURCE: ROCHE
