In the European Union (EU), Humira is now the first and only medication approved for HS, a painful, chronic inflammatory skin disease, also referred to as ‘acne inversa’.
The disease is characterized by recurrent, painful abscesses and nodules on the skin typically around the armpits and groin, on the buttocks and under the breasts.
Erasmus Medical Center professor Errol Prens said: "HS patients often experience painful and embarrassing symptoms that can have a detrimental impact on their lives.
"Humira is the first approved, well-documented treatment shown to reduce HS symptoms including pain, marking an important advancement in the management of HS."
The approval is based on the results of two 36-week, two-period pivotal Phase III trials Pioneer I and Pioneer II in 633 people with moderate to severe HS.
In these trials, patients were randomly assigned to receive either Humira or placebo in addition to daily use of topical antiseptic.
Data from these trials show that patients given Humira had greater reductions in the numbers of abscesses and inflammatory nodules than patients given placebo.
AbbVie research and development executive vice-president and chief scientific officer Michael Severino said: "The approval of Humira is a critical milestone in the lives of people with HS who, up until this point, had no approved treatments.
"This approval represents the 13th global indication for Humira, and demonstrates our commitment to advancing care for patients with serious immune-mediated conditions."