Shots:

• The approval is based on P-III ENVISION I study that involves assessing the efficacy- safety- and PK of Humira (SC) in pediatric patients aged 4-17yrs. with mod. to sev. UC
• The study met its co-1EPs of clinical remission @8wks- patients who responded @8wks- achieved clinical remission @52wks.- no new safety signals were identified
• Humira is the 1st SC anti-TNF therapeutic option for pediatric patients from 5yrs. of age with the mod. to sev. active UC who had an inadequate response to conventional therapy including corticosteroid and azathioprine or 6-mercaptopurine or who are intolerant to such therapies

  Ref: Newswire Canada | Image: abbvie