AbbVie (ABBV) Receives Positive CHMP Opinion for HUMIRA as HS Treatment

November 14, 2016 6:13 AM EST

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AbbVie (NYSE: ABBV) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for HUMIRA (adalimumab) for the 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. If approved, HUMIRA will become the first and only biologic treatment option for patients 12 years of age and older. HUMIRA was approved for adults with moderate to severe HS by the European Commission in July 2015.

"Hidradenitis suppurativa can start at puberty and become worse over time. It is important for patients to receive an early and accurate diagnosis and treatment to better manage the life course effects of the disease," said John Medich, Vice President, Immunology Clinical Development, AbbVie. "This positive CHMP opinion is a significant milestone for patients impacted by this painful, chronic disease as there are currently no approved medications available for adolescents to treat it."

Hidradenitis suppurativa, sometimes referred to as "acne inversa" by dermatologists, is a painful, debilitating, chronic inflammatory skin disease estimated to affect 1 – 4 percent of the world's population.1-2 The prevalence of HS among adolescents between the ages of 12 and 17 years is estimated to be 0.09 percent (298 adolescents diagnosed with HS out of 328,634 total adolescents sampled).3 The condition is characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.1-2 HS can have considerable impact on patients' quality of life, physical activities and emotional state.1-2,4 The disease can be challenging to diagnose, with studies showing it can take up to eight years for people with HS to receive an accurate diagnosis.1-2,5

Since first gaining approval 13 years ago, HUMIRA has been approved in more than 90 countries across 14 globally approved indications,6-7 and is currently being used to treat more than a million patients worldwide.8



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