US regulators have approved the first drug - AbbVie’s Humira - to treat the inflammatory skin disease hidradenitis suppurativa, giving patients an alternative to surgery and antibiotics.
Humira (adalimumab) has been cleared by the US Food and Drug Administration for moderate-to-severe forms of the condition, which is characterised by inflamed, painful lesions typically located around the armpits and groin, on the buttocks and under the breasts.
Approval is based on data from two pivotal Phase III studies, PIONEER I and PIONEER II, which the firm says showed that more patients taking its drug had reductions in the total number of abscesses and inflammatory nodules than those on placebo.
Humira has also been awarded orphan drug status by the FDA as its target population is less than 200,000 patients.
The drug is TNF blocker medicine that affects the immune system and can lower the body's ability to fight infections, and the approval in HS marks its ninth in the US.