Japanese regulators hand first global approval to AbbVie, Boehringer Ingelheim's IL-23 inhibitor Skyrizi

AbbVie announced Tuesday that the Japanese Ministry of Health, Labour and Welfare approved Skyrizi (risankizumab) for the treatment of plaque psoriasis, generalised pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who have an inadequate response to conventional therapies. The company, which is developing the drug with Boehringer Ingelheim, noted that the clearance marks the first approval for the IL-23 inhibitor.  

Approval of the drug in Japan was backed by efficacy and safety data from several Phase II and Phase III studies. In research data unveiled in early 2018, Skyrizi was associated with significantly higher rates of skin clearance at week 16 and at one year of treatment compared to Johnson & Johnson's Stelara (ustekinumab).  

"With this first global approval of Skyrizi, we are excited to bring a new treatment option to people living with psoriatic disease in Japan," remarked AbbVie president Michael Severino, adding "we look forward to continuing to work with regulatory authorities to make this treatment available to more patients worldwide." 

Last month, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Skyrizi for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy, while the IL-23 inhibitor is currently under review by the FDA, with a decision expected in the first half of this year. 

The treatment was also previously awarded orphan drug status by the FDA for the treatment of children with Crohn's disease. 

For related analysis, see ViewPoints: The end of an era - AbbVie begins planning for life after Humira. 

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