Abbott's Humira OKed for new ulcerative colitis indication in EU

Following a previous favorable advisory committee recommendation, US health care major Abbott Laboratories (NYSE: ABT) said yesterday that the European Commission has now approved its Humira (adalimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy.

With this approval, Humira becomes the first and only self-injectable biologic therapy for the treatment of moderately to severely active ulcerative colitis in adults. The approval also marks the seventh indication for Humira in the European Union since the product's first clearance in 2003.

Humira is the group’s best-selling drug and will be part of the new AbbVie that the company intends to be a split-off for its research-based drug business into a separate publicly-traded company (The Pharma Letter March 22). Humira’s global sales increased 21.1% to $7.9 billion in 2011,