Roche announces FDA approval of ACTEMRA

Roche has announced the Food and Drug Administration’s (FDA’s) approval of its rheumatoid arthritis (RA) therapy ACTEMRA (tocilizumab).

It is indicated for the treatment of adult patients with moderate to severe active RA who have failed to respond to one or more tumor necrosis factor (TNF) antagonist therapies.

ACTEMRA can be used on its own or in combination with other disease modifying anti-rheumatic drugs.

“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,” commented Hal Barron, executive vice-president of global development and chief medical officer of Roche and Genentech.

ACTEMRA was developed alongside Chugai and is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved for the treatment of RA.

In other Roche news, the organisation resolved a dispute with Amgen last month that arose from the patents for the latter firm’s recombinant erythropoietin.