) 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
Johnson & Johnson
) Remicade and Simponi.
We currently have a Neutral recommendation on Abbott Labs, which
carries a Zacks #3 Rank (short-term 'Hold' rating).
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