European Commission approves Humira for hidradenitis suppurativa

AbbVie announced that the European Commission has approved Humira for treating moderate-to-severe hidradenitis suppurativa in adults with inadequate response to conventional treatment.

Humira (adalimumab) is the first medication approved for hidradenitis suppurativa (HS) in the European Union, according to a press release. An estimated 1% of the worldwide adult population is impacted by the disease, which also is known as “acne inversa.”

“HS patients often experience painful and embarrassing symptoms that can have a detrimental impact on their lives,” Errol Prens, MD, PhD, professor, Erasmus Medical Center, Rotterdam, Netherlands, said in the release. “Humira is the first approved, well-documented treatment shown to reduce HS symptoms including pain, marking an important advancement in the management of HS.”

Results of the 36-week, phase 3 PIONEER I and PIONEER II studies in 633 patients with moderate-to-severe HS were the basis for the marketing authorization, the release said. Patients were randomly assigned adalimumab or placebo plus daily use of topical antiseptic. In both studies, patients assigned adalimumab had greater reductions in abscesses and inflammatory nodules compared with the placebo-treated patients. There was a clinically relevant decrease in HS-related skin pain reported in patients treated with adalimumab vs. placebo at week 12 in PIONEER II. There were no new safety signals identified in the studies, according to the release.

Adalimumab is not indicated for patients with active tuberculosis, other severe infections or moderate-to-severe heart failure, according to the release. Serious infections, which in rare cases could be life-threatening, have been reported with adalimumab use.

The FDA granted orphan drug designation to Humira for treating moderate-to-severe hidradenitis suppurativa in May, according to AbbVie.

Reference: www.abbvie.com