Adalimumab gets new indication for hidradenitis suppurativa.
Adalimumab (Humira/AbbVie) has a new indication. The US Food and Drug Administration has approved its use treating a chronic inflammatory skin disease known as moderate to severe hidradenitis suppurativa.
The condition leads to inflamed lesions in areas where the skin rubs together, such as near the armpits and groin, between the buttocks, and under the breasts.
Humira was granted orphan drug designation for the treatment of moderate to severe hidradenitis suppurativa (Hurley Stage II and Hurley Stage III disease).
Alexa Kimball, MD, MPH, 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 said in a news release, "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."
The FDA approval was based on the review of data from 2 pivotal Phase 3 studies that included 633 people with moderate to severe hidradenitis suppurativa. Both studies showed that more patients given Humira had reductions in the total number of abscesses and inflammatory nodules compared to patients given placebo. No new safety risks were identified in these trials.
Images of the condition are available here.
Humira already has FDA approval for use in treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis, and chronic plaque psoriasis.
The new indication has been approved in Europe since July.