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FDA approves Humira for hidradenitis suppurativa
11 September 2015 • Author: Victoria White
The US Food and Drug Administration (FDA) has approved AbbVie’s Humira (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa.
Humira is now the first and only FDA-approved therapy for adults with hidradenitis suppurativa.
Hidradenitis suppurativa is a chronic inflammatory skin disease characterised 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 hidradenitis suppurativa (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 hidradenitis suppurativa.
Other treatment options for people with hidradenitis suppurativa include surgery to remove skin affected by the disease and antibiotics to treat infections that may occur. Hidradenitis suppurativa can be progressive in some people, and diagnosing and managing the disease early is important. This can be difficult, and many people with hidradenitis suppurativa experience a lengthy delay in diagnosis and treatment. It’s important for hidradenitis suppurativa patients and people who think they may have hidradenitis suppurativa to see a dermatologist who is trained to recognise and manage the disease.
Humira significantly reduced signs of hidradenitis suppurativa in clinical trials
“The symptoms of hidradenitis suppurativa, 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 hidradenitis suppurativa in clinical trials, and this FDA approval provides a much needed development in treatment options for patients.”
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 hidradenitis suppurativa. 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.
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 hidradenitis suppurativa treatment in the European Union.
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