AbbVie's Humira (adalimumab) receives U.S. FDA approval for moderate to severe hidradenitis suppurativa

FDA

10 September 2015 - AbbVie, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS). Humira is now the first and only FDA-approved therapy for adults with HS.

Hidradenitis suppurativa is a chronic inflammatory skin disease characterized by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts. Earlier this year, the FDA granted Humira orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS.

Other treatment options for people with HS include surgery to remove skin affected by the disease and antibiotics to treat infections that may occur. HS can be progressive in some people, and diagnosing and managing the disease early is important.4 This can be difficult, and many people with HS experience a lengthy delay in diagnosis and treatment. It's important for HS patients and people who think they may have HS to see a dermatologist who is trained to recognize and manage the disease.

For more details, go to: http://abbvie.mediaroom.com/2015-09-10-AbbVies-HUMIRA-Adalimumab-Receives-First-and-Only-U-S-Food-and-Drug-Administration-Approval-for-Moderate-to-Severe-Hidradenitis-Suppurativa

Michael Wonder

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Michael Wonder

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