FDA finally approves Roche's Actemra for moderately-to-severely active rheumatoid arthritis

Coming more than a year after the US Food and Drug Administration first asked for more data on the drug despite an advisory committee's backing for it, the agency has now given final approval for Swiss drug major Roche's Actemra (tocilizumab) for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies, opening the way for the Genentech-developed agent to challenge top-selling RA products from Amgen, Johnson & Johnson and Abbott Laboratories.

Actemra, Roche said, is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).The disease affects an estimated 1.3 million Americans, according to data from the USA's National Institutes of Health. Actemra is already approved in the European Union, as well as Japan and Australia, but has had limited sales because of regulatory delays in the USA, the world's largest pharmaceutical market.

"The FDA approval of Actemra  marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease,' said Hal Barron, executive vice president, Global Development and chief medical officer, Roche and its subsidiary Genentech. '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 and are committed to comprehensively characterizing both the clinical benefit and the safety of Actemra in earlier lines of therapy through our large pharmacovigilance program, including the risk management program, and ongoing clinical and post-marketing studies globally," he added.