AbbVie’s aging rheumatoid arthritis drug Humira has been approved as the first EU treatment for the skin disease hidradenitis suppurativa (HS).
HS, which is also known as acne inversa, is a painful, chronic inflammatory skin disease characterised by recurrent, painful abscesses and nodules on the skin – typically around the armpits and groin, on the buttocks and under the breasts.
The European Comission approval is based on the PIONEER Phase III studies, which showed that patients given Humira (adalimumab) had greater reductions in the numbers of abscesses and inflammatory nodules than patients given placebo.
"HS patients often experience painful and embarrassing symptoms that can have a detrimental impact on their lives," says Professor Errol Prens of Erasmus Medical Center. "Humira is the first approved, well-documented treatment shown to reduce HS symptoms including pain, marking an important advancement in the management of HS."
Humira is the world’s biggest-selling drug – but its patents expire in 2016 and AbbVie has yet to produce a drug that can replicate its success.