Sales of Actemra are likely to be boosted after Roche noted that regulators have expanded approval on the rheumatoid arthritis treatment.
The US Food and Drug Administration has now approved Actemra (tocilizumab) for the treatment of adults with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Actemra, an interleukin-6 receptor-inhibiting monoclonal antibody, can be used as a single-agent therapy and in combination with methotrexate or other DMARDs.
The expanded indication is based on Phase III trials which were previously available, "safety data collected from the post-marketing experience with Actemra since approval in 2010, as well as data from other clinical studies, including those (from) a real-world setting," Roche noted. The drug, marketed as RoActemra elsewhere, had previously been available for patients who have had an inadequate response to one or more tumour necrosis factor antagonist therapies.
Roche chief medical officer Hal Barron noted that people with moderately to severely active RA "can suffer irreversible joint damage that may be prevented by earlier treatment with a biologic medicine such as Actemra". The expanded approval should lift sales of the drug which is already a big earner; sales for the first six months of 2012 reached 385 million euros, a leap of 39%.