AbbVie has announced that the European Commission (EC) has approved its interleukin-23 (IL-23) inhibitor Skyrizi (risankizumab), for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
The approval was based on results from four Phase III studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance which evaluated more than 2,000 patients with moderate to severe plaque psoriasis and found high rates of skin clearance with Skyrizi at 16 weeks.
After the 16 weeks of treatment, 88% of the ultIMMa-1 trial and 84% of the ultIMMa-2 trial achieved ‘clear or almost clear’ on the Physician Global Assessment (sPGA) score.
The drug is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.
“This approval is an important step forward in providing people living with moderate to severe psoriasis with a new treatment option,”
said Michael Severino, vice chairman and president, AbbVie.
“The results seen in our clinical studies, including high levels of complete skin clearance with 12-week dosing and a favourable safety profile, suggest Skyrizi has the potential to provide long-term relief from the signs and symptoms of psoriasis. We are proud to expand our portfolio of treatment options for people living with this condition in Europe.”
Psoriasis affects around 2% of people in the UK and 125 million people worldwide. It can start at any age but most often develops in adults under 35 years old, and affects men and women equally.