AbbVie Inc. said Skyrizi received its first country approval from Japan's Ministry of Health, Labour and Welfare to treat adults with certain forms of psoriasis.
Skyrizi, or risankizumab, can now be used in Japan to treat plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies.
Psoriasis is a chronic, immune-mediated disease characterized by raised, red, scaly patches on the skin.
The approval was supported by the effectiveness and safety data from mid- and late-stage trials — sustaIMM, ultIMMa-1 and IMMspire — which evaluated Skyrizi in Japanese patients with the disease. A global mid-stage study among patients with active psoriatic arthritis also backed the Japanese health agency's decision.
On March 1, the European Medicines Agency recommended the approval of Skyrizi for treating moderate to severe psoriasis.
AbbVie said it is looking at Skyrizi, together with upadacitinib, to replace its best-selling immunology drug Humira which is facing biosimilar competition.
Boehringer Ingelheim GmbH and AbbVie are collaborating on Skyrizi.