AbbVie Inc. (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive recommendation for the label expansion of its lead prescription drug, Humira for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adolescents aged 12 years and above.
In Jul last year, Humira was granted marketing approval for the same indication in adults by the European Commission. Upon approval for the latest filing, Humira will become the first and only biologic treatment option for patients aged 12 years and above.
Humira is an anti-inflammatory product currently approved for several other indications such as the reduction of 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 aged 6 years and above. The drug has been approved in more than 90 countries across 14 globally approved indications and is currently used in the treatment of more than a million patients worldwide.
Moreover, Humira enjoys orphan drug status for the treatment of moderate-to-severe HS (Hurley stage II and Hurley stage III disease), which makes the product eligible for seven years of market exclusivity in this indication.
Per the company’s press release, 298 adolescents, representing around 0.09% of a total 328,634 adolescents sampled, aged between 12 and 17 years, have been diagnosed with HS. Hence, an approval of Humira in this indication would give the company access to a huge population of patients.
We note that Humira is the key growth driver at AbbVie. The drug garnered sales of $4 million in the third quarter of 2016, representing more than 66% of the company’s total revenue.
Zacks Rank & Key Picks
AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Cambrex Corp. (CBM - Free Report) and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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