AbbVie has received approval from the European Commission (EC) for its Humira (adalimumab) to treat moderate-to-severe hidradenitis suppurativa (HS or acne inversa), which is a painful and chronic inflammatory skin disease.
The drug has obtained approval to treat HS in adults, which cannot be treated through conventional systemic HS treatment.
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AbbVie research and development executive vice-president and chief scientific officer Dr 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."
The approval was based on the results of two 36-week and two-period pivotal Phase III studies, including Pioneer I and Pioneer II, in 633 people with moderate to severe HS.
The company had randomly assigned patients in these studies to receive either Humira or placebo, in addition to daily use of topical antiseptic.
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By GlobalDataAccording to the firm, the studies demonstrated that patients received Humira had greater reductions in the numbers of abscesses and inflammatory nodules compared to patients received placebo.
Humira received approval in around 87 countries and is claimed to be currently used to treat around 850,000 patients across the globe through 13 globally approved indications.
In this month only, AbbVie obtained EC marketing approval for its Imbruvica (ibrutinib) to treat patients with Waldenstrom’s macroglobulinemia (WM), a rare and slow-growing blood cancer.
