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Humira Approved for Moderate-to-Severe Hidradenitis Suppurativa

The FDA had granted an orphan drug designation

The FDA has approved adalimumab (Humira, AbbVie) for the treatment of moderate-to-severe hidradenitis suppurativa (HS). Humira is now the first and only FDA-approved therapy for adults with this disease.

HS 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 an 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 gives 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. This can be difficult, and many people with HS experience a lengthy delay in diagnosis and treatment.

This FDA approval is based on the results of two pivotal phase III studies, PIONEER I and PIONEER II, and represents the ninth approved indication for Humira in the U.S.

PIONEER I and PIONEER II included 633 people with moderate-to-severe HS. Patients in these studies were randomly assigned to receive either adalimumab or placebo in addition to daily use of topical antiseptic. Both studies showed that more patients given adalimumab had reductions in the total number of abscesses and inflammatory nodules than patients given placebo. No new safety risks were identified in these trials. 

Source: AbbVie; September 10, 2015.

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