Humira for adults with hidradenitis suppurativa gets positive opinion in Europe
The European Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for Humira to treat active to moderate-to-severe hidradenitis suppurativa in adults who had inadequate response to conventional therapy.
Data from two phase 3 studies (PIONEER I and PIONEER II) were the basis of the positive opinion, according a press release. In the studies, patients with moderate-to-severe hidradenitis suppurativa were treated with Humira (adalimumab, AbbVie) 40 mg weekly beginning at week 4 following a 160 mg dose at week 0 and an 80 mg dose at week 2. At week 12, the adalimumab-treated cohort achieved a significantly greater response on the Hidradenitis Suppurativa Clinical Response measure compared with patients treated with placebo. In the PIONEER II study, a significantly higher proportion of patients treated with adalimumab experienced at least a 30% reduction in skin pain caused by hidradenitis suppurativa, compared with the placebo-treated cohort.
“The positive opinion from the Committee for Medicinal Products for Human Use is a significant milestone for people with hidradenitis suppurativa in Europe because it represents progress toward the first and only approved medicine for this devastating disease,” Michael Severino, MD, executive vice president, research and development, and chief scientific officer, AbbVie, said in a press release.
Hidradenitis suppurativa, also referred to as “acne inversa,” is an inflammatory skin disease that affects approximately 1% of the world’s adult population, the release stated. Recurrent, painful abscesses and nodules typically located around the armpits and groin, on the buttocks and under the breasts are characteristics.
If the European Commission grants approval, adalimumab will become the first medication approved for hidradenitis suppurativa, according to the release. If approved, authorization would be valid in all 28 member states of the European Union, as well as in Iceland, Norway and Lichtenstein.
AbbVie announced in May that the FDA has granted orphan drug designation to Humira for treating moderate-to-severe hidradenitis suppurativa. The supplemental biologic license application by Abbvie seeking the agency’s approval for the use of Humira in patients with moderate-to-severe hidradenitis suppurativa (Hurley Stage II and Hurley Stage III disease) is being reviewed by the FDA.
Humira currently is indicated for treating moderate-to-severe plaque psoriasis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis in adults and moderate-to-severe juvenile idiopathic arthritis.