The FDA approved AbbVie’s 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.

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.

This FDA approval is based on the results of two pivotal Phase 3 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. More information on PIONEER I and PIONEER II is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233, respectively).

In July, the European Commission approved HUMIRA for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment in the European Union.

Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries and is currently being used to treat more than 843,000 patients worldwide, according to AbbVie.

"The symptoms of HS, including inflamed nodules and abscesses, can have a significant impact on patients during their most active years of life," said Alexa Kimball, M.D., M.P.H., director of the Clinical Unit for Research Trials and Outcomes in Skin at Massachusetts General Hospital, professor of dermatology at Harvard Medical School and principal investigator. "Adalimumab significantly reduced the signs of HS in clinical trials, and this FDA approval provides a much needed development in treatment options for patients."