AbbVie (NYSE: ABBV) 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.1-2 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.3 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.1-2 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.4
“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.”
“We are pleased that people living with hidradenitis suppurativa now have an FDA-approved treatment option for this chronic, debilitating disease,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “AbbVie is committed to making a remarkable impact on the lives of patients, and hidradenitis suppurativa is an area of particular unmet need.”
The FDA approval for HS adds to the comprehensive record of clinical studies that HUMIRA has established over its 17 years of use in immunology. 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 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 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.5-6 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.7
Since first gaining approval 12 years ago, HUMIRA has been approved in more than 87 countries. It is currently being used to treat more than 843,000 patients worldwide.8
|1.||Dufour DN, Emtestam L, Jemec GB. Hidradenitis Suppurativa: A Common and Burdensome, Yet Under-Recognised, Inflammatory Skin Disease. Postgrad Med J. 2014; 90 (1062):216-21.|
|2.||Jemec G. Hidradenitis Suppurativa. N Engl J Med. 2012; 366:158-64.|
|3.||Mayo Health Clinic. Hidradenitis Suppurativa. Available at: http://www.mayoclinic.org/diseases-conditions/hidradenitis-suppurativa/basics/definition/con-20027334. Published April 9, 2013. Accessed August 12, 2015.|
|4.||American Academy of Dermatology. Hidradenitis suppurativa. Available at: http://www.aad.org/dermatology-a-to-z/diseases-and-treatments/e—h/hidradenitis-suppurativa. Accessed August 12, 2015.|
|5.||Safety and Efficacy of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from First 12 Weeks of PIONEER I, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract #210 44th Annual Meeting of the European Society for Dermatological Research (ESDR), Copenhagen, Denmark 2014.|
|6.||Efficacy and Safety of Adalimumab in Patients with Moderate to Severe Hidradenitis Suppurativa: Results from PIONEER II, a Phase 3, Randomized, Placebo-Controlled Trial. Abstract FC08.2. 22nd Congress of the European Dermatology and Venereology (EADV) Meeting, Amsterdam, Netherlands 2014.|
|7.||HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; August 2015. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000481/human_med_000822.jsp&mid=WC0b01ac058001d124. Accessed August 12, 2015.|
|8.||AbbVie Data on File.|
|9.||Humira Injection [Package Insert]. North Chicago, IL: AbbVie Inc.|