Roche RA treatment wins committee approval

A new treatment for rheumatoid arthritis (RA) was given approval this week following a review by the Food and Drug Administration (FDA).

Roche’s Actemra (tocilizumab) drug, which was co-researched and developed with Chugai, was given the recommendation following the company’s presentation of positive results from five Phase III clinical trials.

Actmera will be the first interleukin-6 inhibitor (IL-6) capable of offering a new therapeutic option for the treatment of rheumatoid arthritis and could significantly reduce signs and symptoms of the disease in adults.

Commenting on the accreditation, chief executive of Roche’s pharmaceuticals division, William Burns, said the group was pleased with the committees decision.

“[The approval] helps move this promising new therapy closer to becoming available for patients who suffer from the debilitating symptoms of RA,” he said.

The FDA recommendation was won following a 10-1 vote in favour of approval by the committee.

Roche claims the results of clinical testing have so far shown that the Actemra treatment is “generally well tolerated”, with safety profiles consistent across all recent global studies.

Last month, Roche signed an agreement for the acquisition of Arius Research in a deal said to be worth around C$191 million (94 million pounds). Arius’ work includes the development of the proprietary antibody platform, FunctionFirst.