Health Canada clears AbbVie’s Humira for UC

In what is now the eighth indication in Canada for its top-selling drug Humira (adalimumab), US drugmaker AbbVie’s (NYSE: ABBV) arthritis product has now also been cleared for ulcerative colitis (UC).

Health Canada approved Humira for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids, azathioprine and/or 6-mercaptopurine (6-MP) or who are intolerant to such therapies.

The efficacy of Humira in patients who have lost response to or were intolerant to TNF blockers has not been established. With this indication, is also approved in Canada in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), and psoriasis (Ps), as well as in children aged four to 17 years for the treatment of polyarticular juvenile idiopathic arthritis (JIA) and in pediatric patients with Crohn's disease (CD) 13 to 17 of age, ≥40kg.