Roche looks to be on track to get approval on both sides of the Atlantic for Actemra, its novel biologic for the treatment of rheumatoid arthritis.

At the meeting of the European League Against Rheumatism in Paris, new data on Actemra (tocilizumab) was presented showing consistent clinical efficacy – and equally importantly, no new safety signals came to light. In the AMBITION trial, Roche’s drug showed superiority over methotrexate – the current standard of care in RA, making it the only biologic to achieve a greater reduction of signs and symptoms of the disease than MTX.

New Phase III data were also presented from the RADIATE trial in combination with MTX which showed that Actemra provided rapid and significant improvement in signs and symptoms of RA than MTX plus placebo in patients with an inadequate response to tumour necrosis factor inhibitors. Significantly more patients in the Actemra plus MTX group showed reduced symptoms and achieved disease remission following 24 weeks of treatment, compared with MTX alone.

The new data now give Actemra a ‘full house’ of clinical efficacy data, with completed studies now showing efficacy across the spectrum of RA. “This is the most complete data set we have ever had in rheumatology – tocilizumab has the potential to be used at every stage of the disease,” said Paul Emery of the University of Leeds and lead investigator on RADIATE.

Actemra, which is awaiting approval in the USA and Europe, was launched by Chugai in Japan in June 2005 as a therapy for Castleman's disease; in April 2008, additional indications for RA, polyarticular-course juvenile idiopathic arthritis and systemic-onset JIA were also approved in Japan.

With the drug submitted for US Food and Drug Administration approval in November 2007, Roche may get the green light in time for this October’s San Francisco meeting of the American College of Rheumatology. “EULAR was the engagement party, but ACR could be the wedding,” as one industry analyst put it.