Illinois-based pharmaceutical firm Abbvie has submitted a marketing authorization application to the European Medicines Agency for its investigational plaque psoriasis therapy risankizumab, the company’s Korean branch said Thursday.
Risankizumab is an interleukin-23 inhibitor developed in collaboration with Boehringer Ingelheim to treat patients with moderate to severe plaque psoriasis. Plaque psoriasis is a skin disease often characterized by itchy, painful, red patches on the body.
Abbvie said it applied for the marketing approval having gained supporting data from its global Risankizumab phase 3 psoriasis program that studied more than 2,000 patients with moderate to severe plaque psoriasis in four pivotal phase 3 studies.
Data showed that risankizumab met all co-primary endpoints and no notable safety problems found, the company said.
"Risankizumab has the potential to be an important new treatment option, and we look forward to working with the EMA throughout the review process," said Michael Severino, AbbVie’s executive vice president and R&D officer and CSO.
The risankizumab submission to the EMA marks another significant milestone in helping to advance treatment for people living with immune-mediated diseases, he added.