Health Canada backs pediatric Humira for Crohn's

US drugmaker AbbVie (NYSE: ABBV) says that Health Canada has approved its blockbuster rheumatoid arthritis drug Humira (adalimumab) for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 13 to 17 years of age weighing ≥ 40kg with severely active Crohn's disease and/or who have had an inadequate response or were intolerant to conventional therapy (a corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a tumor necrosis factor alpha antagonist.

With this approval, Humira, which generated global sales of $2.61 billion in the second quarter of 2013, becomes the first biologic treatment in the form of a subcutaneous injection approved for these patients. Furthermore, it is Humira’s second approval in the field of inflammatory bowel disease (IBD) after adult Crohn's disease, and the seventh approval for the treatment of immune mediated inflammatory diseases in Canada.

Canada has one of the highest rates of childhood-onset IBD