FDA approves Humira (adalimumab) for hidradenitis suppurativa-AbbVie

The FDA has approved Humira (adalimumab), from AbbVie, for the treatment of moderate to severe hidradenitis suppurativa (HS). It is the first and currently the only FDA-approved therapy for adults with HS. In July, the European Commission approved Humira for the treatment of active moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS treatment in the European Union.

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