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AbbVie's Humira Gains FDA Approval for Label Expansion

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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 patients suffering from moderate-to-severe hidradenitis suppurativa (HS). Approval makes Humira the first and only FDA-approved treatment for this indication.

The U.S. approval comes after Humira gained approval in the EU in Jul 2015 for the treatment of active moderate-to-severe HS in adults who have had an inadequate response to conventional systemic HS treatment.

We note that this is the ninth FDA approval for Humira over a period of 12 years. Humira is currently approved for several indications including reduction of the signs and symptoms of psoriatic arthritis, ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, Crohn’s disease (CD), ulcerative colitis and chronic plaque psoriasis arthritis in the U.S. It is also approved for the treatment of moderate-to-severe CD in children 6 years of age and older.

Humira has orphan drug status for the treatment of moderate-to-severe HS (Hurley stage II and Hurley stage III disease). The orphan drug status should now make Humira eligible for seven years of market exclusivity for this indication.

We are encouraged by the label expansion of Humira. Humira is the key growth driver at AbbVie. In the first half of 2015, Humira generated global revenues of $6.6 billion, an increase of 12.2% year over year. Label expansion should boost the drug’s sales further.

Meanwhile, AbbVie is working on expanding Humira’s label further. The company is evaluating Humira for the treatment of adults with uveitis. Regulatory applications in the U.S. and EU are planned for the second half of 2015.

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Dr. Reddy's Laboratories Ltd. (RDY - Free Report) , Gilead Sciences Inc. (GILD - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . All three carry a Zacks Rank #1 (Strong Buy).

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