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Abbott's Humira's Label Expanded

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Abbott Labs (ABT - Free Report) recently received approval for yet another indication of Humira (adalimumab). The European Commission approved Humira for the treatment of severe active Crohn’s disease (CD) in pediatric patients (6 to 17 years) who failed or are intolerant to or have contraindications to conventional therapy. This approval makes Humira the first biologic treatment to be approved for this patient population in more than five years.

Approval was largely expected as in October, the European Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for Humira for the above indication. According to the company, about 200,000 children suffer from Crohn’s disease across the world.

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.

Abbott Labs has been working on expanding Humira’s label. Some time back, Abbott Labs gained FDA approval for 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 came a few weeks after Abbott Labs gained approval from the European Commission 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.

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

We currently have a Neutral recommendation on Abbott Labs, which carries a Zacks #3 Rank (short-term ‘Hold’ rating). Meanwhile, Johnson & Johnson carries a Zacks #2 Rank (short-term ‘Buy’ rating).


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