After positive research results were presented at the American College of Rheumatology Annual Scientific Meeting earlier this month, Roche announced this week that it has filed for FDA approval of a biologics license application for its drug tocilizumab (marketed as Actemra) for the treatment of signs and symptoms of RA. As Dr. Borigini explained so well in his blog earlier this week, Actemra is a humanized interleukin-6 receptor inhibiting monoclonal antibody. It is the first drug of its kind. Actemra blocks the function of a molecule called interleukin-6, which is involved in the inflammatory response of RA. Roche is also expecting to file an application for approval with the European Medicines Agency (EMEA) in early December.
The drug has been tested in several international Phase III studies. Phase III studies are large scale studies on several hundred to several thousand patients, often lasting several years. The goal of the studies is to build on earlier phases of testing to determine the efficacy, safety and possible side effects of the drug. When drugs successfully complete Phase III testing, the manufacturer can apply for FDA approval for marketing of the drug. The results of the 5 Actemra studies showed that Actemra, either by itself or in combination with disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate significantly reduced the signs and symptoms of rheumatoid arthritis, more so than using DMARDs alone. These findings were determined by measures such as ACR and disease activity score (DAS) remission rates. These five clinical studies included more than 4,000 patients in 40 countries, including the U.S. and Europe.
Roche will file a Marketing Authorisation Application (MAA) for the product with the European Medicines Agency (EMEA) in early December. Roche has developed Actemra in collaboration with Chugai. In Japan, Actemra has been used since June 2005 as a therapy for Castleman's disease and in April 2006, Chugai filed for the additional indications of rheumatoid arthritis and systemic-onset juvenile idiopathic arthritis.
FDA approval of this drug would be exciting news for RA sufferers because this drug represents a new way of affecting cytokines, molecules involved in inflammation. It may reduce joint inflammation and possibly relieve some systemic effects of RA. One of the Phase III studies is still ongoing. It is a two-year study evaluating the effect of Actemra on the inhibition of structural damage. Roche is expecting to report the results of the first year data in 2008.
What interests me about this drug is that it is administered in adults intravenously every four weeks. Plus, even though it carries more of a risk of serious infections than DMARDs, so far I have not seen reports showing the marked increased risk of cancer that is associated with the anti-TNF inhibitors. Maybe data showing cancer risk hasn't developed because the testing hasn't been going on long enough to determine whether there is a cancer risk. I will be watching the news and Dr. Borgini's blog for more information about this drug over time.
Published On: November 30, 2007