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AbbVie Humira Gains FDA Approval for Yet Another Indication
AbbVie Inc. (ABBV - Free Report) announced a label expansion for its anti-inflammatory drug, Humira, in the U.S. With the label expansion, Humira can now be used for the treatment of adults suffering from non-infectious intermediate, posterior and panuveitis. Approval makes Humira the first and only FDA-approved non-corticosteroid treatment for this indication.
We note that this is the tenth FDA approval for Humira in the U.S. This approval comes after Humira gained approval in the EU last month for the treatment of non-infectious intermediate, posterior and panuveitis in adults who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Humira is currently approved in the U.S. for several indications including psoriatic arthritis, ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, Crohn’s disease (CD), hidradenitis suppurativa, ulcerative colitis, and chronic plaque psoriasis. It is also approved for the treatment of moderate-to-severe CD in children six years of age and older.
We note that Humira enjoys orphan drug status in the U.S. for the treatment of certain forms of uveitis, which affect a population of fewer than 200,000 patients. The orphan drug status should now make Humira eligible for seven years of market exclusivity for the treatment of adults with non-infectious intermediate, posterior and panuveitis.
We note that Humira is the key growth driver at AbbVie. The drug recorded total sales of $14 billion in 2015, reflecting an 11.7% surge. Label expansion should boost the commercial potential of the drug.
AbbVie is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include Pfizer Inc. (PFE - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Johnson & Johnson (JNJ - Free Report) . While Pfizer and Bristol-Myers are Zacks Rank #1 (Strong Buy) stocks, Johnson & Johnson carries a Zacks Rank #2 (Buy).
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