) 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
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
Johnson & Johnson
) 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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