Posted by Michael Wonder on 23 Apr 2021
AbbVie receives Health Canada approval of Humira (adalimumab) for the treatment of paediatric patients with moderately to severely active ulcerative colitis
22 April 2021 - Approval based on results from the pivotal Phase 3 ENVISION I trial, the largest clinical trial in paediatric ulcerative colitis to date, showing Humira provided significant rates of response and remission both at week 8 and 52.
AbbVie today announced that Health Canada has approved Humira (adalimumab) for inducing and maintaining clinical remission in paediatric patients five years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy including corticosteroids and/or azathioprine or 6-mercaptopurine or who are intolerant to such therapies.
