New Indication for Abbott's Humira

Abbott Labs ( ABT - Analyst Report ) recently announced that it has received approval for an additional indication of Humira (adalimumab) from the US Food and Drug Administration (FDA). The FDA approved Humira for inducing and sustaining clinical remission in adult patients suffering from moderately to severely active ulcerative colitis when certain other medicines have not worked sufficiently.

Approval for this indication comes a few weeks after Abbott Labs gained approval from the European Commission (EC) for Humira for the treatment of moderately active Crohn's disease in adult patients who have responded inadequately to conventional therapy. Earlier this year, Humira had gained EC approval for the treatment of adults with severe axial spondyloarthritis (axSpA) who have no X-ray evidence of structural damage.

We note that Abbott Labs gained EC approval for Humira in April 2012 for treating adults suffering from moderately to severely active ulcerative colitis. The product gained approval for use in patients who did not respond satisfactorily to standard drugs for ulcerative colitis treatment.

Humira is a key product in Abbott Labs' pharmaceutical products portfolio. Humira is approved for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, juvenile idiopathic arthritis, and Crohn's disease. Humira sales increased 21.1% to $7.9 billion in 2011. Growing awareness, favorable clinical data, additional indications and expansion into new markets like China and Japan should help the product to continue contributing significantly to the top-line.

Other players in the anti-inflammatory market include Pfizer/Amgen’s ( PFE - Analyst Report ) / ( AMGN - Analyst Report ) Enbrel, Johnson & Johnson/Merck’s ( JNJ - Analyst Report ) / ( MRK - Analyst Report ) Remicade and Simponi.

We currently have a Neutral recommendation on Abbott Labs, which carries a Zacks #3 Rank (short-term ‘Hold’ rating).