AbbVie has submitted a marketing authorisation application (MAA) for its psoriasis drug risankizumab to secure approval from the European Medicines Agency (EMA).
Developed as part of the company’s alliance with Boehringer Ingelheim, risankizumab is designed to selectively inhibit IL-23 by binding to p19 sub-unit. It has been approved to treat moderate-to-severe plaque psoriasis.
IL-23 is associated with various chronic immune-mediated diseases, and risankizumab could potentially provide long-term skin clearance for psoriasis patients.
AbbVie chief scientific officer and research and development executive vice-president Michael Severino said: “The risankizumab submission to the EMA marks another significant milestone in helping to advance treatment for people living with immune-mediated diseases.
“Risankizumab has the potential to be an important new treatment option and we look forward to working with the EMA throughout the review process.”
The application includes findings from the Phase III psoriasis programme that involved more than 2,000 participants with moderate-to-severe plaque psoriasis in four pivotal clinical trials.
Designed to evaluate risankizumab’s safety and tolerability, the trials also examined efficacy measures such as disease activity and skin clearance, along with long-term clinical outcomes.
In all the trials, risankizumab met co-primary and ranked secondary endpoints without any new safety signals.
The company is currently assessing risankizumab in other Phase III trials for psoriasis, Crohn’s disease and psoriatic arthritis, with plans to test the drug candidate in patients suffering from ulcerative colitis.