FDA extends use of Genentech rheumatoid arthritis drug

Actemra includes labeling for inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX).

Genentech claims that Actemra is a humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

The FDA’s decision was based on data from a randomized, double-blind, placebo-controlled Phase III LITHE trial which demonstrated that patients receiving Actemra in combination with methotrexate had less damage to their joints at one year, compared to patients in control group.