BRIEF — AbbVie submits risankizumab MAA in psoriasis

US drugmaker AbbVie has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for the treatment of patients with moderate to severe plaque psoriasis.

This comes a week after  AbbVie submitted a Biologics License Application to the US Food and Drug Administration for risankizumab in the same indication.
Risankizumab is part of a collaboration with privately-owned German pharma Boehringer Ingelheim, with AbbVie leading future development and commercialization globally.

It is one of the drugs that AbbVie is hoping will help to replace the revenues lost due to the arrival of competitors to its arthritis drug Humira (adalimumab) in the next five years.

Michael Severino, executive vice president, research and development and chief scientific officer, AbbVie, said: “The risankizumab submission to the EMA marks another significant milestone in helping to advance treatment for people living with immune-mediated diseases.

“Many psoriasis patients are still battling this disease and the impact it has on their lives. 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 MAA is supported by data from the global risankizumab psoriasis program evaluating more than 2,000 patients with moderate to severe plaque psoriasis across four pivotal Phase III studies. Across all trials, the drug met all co-primary and ranked secondary endpoints.