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AbbVie Up, Wins CHMP Backing for Humira's Expanded Use

AbbVie Inc. ABBV announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given an opinion in favor of expanding Humira’s label in the EU. The company’s shares gained 3.1% on the news.

Humira is under review in the EU for the treatment of moderately-to-severely active Crohn's disease in pediatric patients (aged six years and above) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

The drug is currently approved in the EU for the treatment of severe active Crohn’s disease in pediatric patients (aged six years and above). With the CHMP issuing a positive opinion, we believe that chances of Humira gaining EU approval for an expanded use are pretty high.

Humira is currently approved in the EU for several indications including the treatment of adults with moderate-to-severe active rheumatoid arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, active and progressive psoriatic arthritis, moderately-to-severely active ulcerative colitis, and active moderate-to-severe hidradenitis suppurativa.

Humira is also approved for use in pediatric patients with active enthesitis-related arthritis, severe chronic plaque psoriasis, and active polyarticular juvenile idiopathic arthritis.

We note that Humira is the key growth driver at AbbVie. The drug recorded total sales of $14 billion in 2015, reflecting a 12% surge. A label expansion should further boost the drug’s sales.

In fact, AbbVie is already working on expanding Humira’s label. The company is evaluating the drug for the treatment of uveitis. Regulatory applications are filed in both the U.S. and the EU with decisions expected in the second half of 2016.

AbbVie is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include AMAG Pharmaceuticals, Inc. AMAG, Actelion Ltd. ALIOF and Emergent BioSolutions, Inc. EBS. All the three stocks sport a Zacks Rank #1 (Strong Buy).

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