AbbVie's Humira a Step Closer to Approval in Europe
- By Alberto Abaterusso
AbbVie Inc. (ABBV) announced yesterday it has received a positive judgment from the European Medicines Agency's Committee for Medicinal Products for Human Use for Humira as "treatment of active moderate to severe hidradenitis suppurativa (HS) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy."
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The hidradenitis suppurativa (HS), or acne inversa, is a chronic skin disease characterized by areas of inflammation, with skin changes ranging from pimples to deep nodules, severe scars and injuries.
The inflammation usually begins to develop in the vicinity of sweat glands, so the hidradenitis suppurativa is more common in the armpits and groin. Less frequent are alterations of the skin developing in other areas of the body.
The exact cause of the disease is currently unknown, but it is known to correlate with changes in the immune system. The hidradenitis suppurativa can occur at any age but is most common in adults. Usually the onset of the disease is around the age of 20 and is less frequent in people over 50.
The company is now waiting for the medication to be approved by the European Commission as a treatment for patients older than 11. If approved, the company says "Humira will become the first and only biologic treatment option" for the group of patients afore mentioned.
In July 2015, the company received the European Commission's approval to use Humira as a therapy in the treatment of adult patients affected by the illness.
Humira, the trade name under which adalimumab is marketed, is AbbVie's main product and sales driver.
The medication is used for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, juvenile idiopathic arthritis, plaque psoriasis, hidradenitis suppurativa, uveitis and pediatric enthesitis-related arthritis.
The company closed its third quarter reporting Humira sales of $4,060, up 11.3% on a year over year basis and down 2.2% from the previous quarter. In the third quarter of 2016, Humira sales represented approximately 63.6% of AbbVie's total adjusted net revenues.
Currently, AbbVie is trading at $62.31, down 66 cents (-1.05%) from the previous trading day.
Disclosure: I have no positions in AbbVie Inc.
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This article first appeared on GuruFocus.
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