FDA approves Roche's Actemra for RA

Roche is celebrating the news that regulators in the USA have given the green light to its rheumatoid arthritis drug Actemra.

Roche's Genentech unit noted that the US Food and Drug Administration has approved Actemra (tocilizumab) for adults with moderate-to-severely RA who have had an inadequate response to one or more tumour necrosis factor antagonist therapies. The drug is the first interleukin-6 receptor-inhibiting monoclonal antibody approved to treat the disease and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs.

The approval is based on data from five Phase III studies, involving more than 4,000 patients. That makes it “the largest clinical development programme for an indication in RA to date”, the company notes.

Hal Barron, chief medical officer at Roche and Genentech, said the FDA approval of Actemra marks “a major step forward in the treatment of RA”. He went on to say that “we are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy” through “our large pharmacovigilance programme”, including a risk management plan, "and ongoing clinical and post-marketing studies globally”.

Roche quoted Mark Genovese, Actemra study investigator and professor of medicine at Stanford University Medical Center as saying that for many RA patients, “treatment with existing therapies does not resolve the painful and debilitating symptoms of the disease”. Data from the studies “clearly establish Actemra and its unique mechanism of action as an important new option”.

Actemra was first approved in Japan and launched by Roche unit Chugai in June 2005 as a therapy for Castleman's disease and then in April 2008 for RA, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis. It was approved as RoActemra in the European Union in January last year, though Roche suffered a blow in the UK in October when the National Institute for Health and Clinical Excellence turned down its use on the National Health Service for RA.