AbbVie Inc.’s (ABBV) Humira gained FDA approval for reducing the signs and symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged ≥2 years.
Humira was initially (2008) approved in the U.S. for polyarticular JIA in patients aged ≥4 years. With the FDA approval, Humira can now be used in an expanded patient population.
In the EU, Humira is approved for the treatment of polyarticular JIA in patients aged 2 years to 17 years.
According to AbbVie, JIA is the most common form of childhood arthritis with nearly 25% of patients suffering from the polyarticular form of the disease. Polyarticular JIA is one of seven types of JIA.
We note that Humira, AbbiVie’s flagship product, is approved for several indications apart from moderate-to-severe polyarticular JIA. These include moderate-to-severe ulcerative colitis, moderate-to-severe chronic plaque psoriasis and reducing the signs and symptoms of several disease conditions like moderate-to-severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and moderate-to-severe Crohn's disease.
Our Take
Humira is the key growth driver at AbbVie. In the first half of 2014, Humira generated total sales of $5.9 billion, up 22.2% year-over-year. It contributed almost 62% to the company’s total net sales during this period. The company expects Humira to continue exhibiting double-digit growth in 2014.
Meanwhile, AbbVie is working on expanding Humira’s label further. Humira is in a phase III study for the treatment of fingernail psoriasis in patients suffering from moderate-to-severe chronic plaque psoriasis.
AbbVie carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Ligand Pharmaceuticals Inc. (LGND), Mallinckrodt plc (MNK) and Actavis plc (ACT). All these stocks carry a Zacks Rank #1 (Strong Buy).
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