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Risankizumab: First Global Approval

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Abstract

Risankizumab (Skyrizi®), a humanised IgG monoclonal antibody that targets the p19 subunit of IL-23, was developed by AbbVie in collaboration with Boehringer Ingelheim for the treatment of immunological and inflammatory disorders. In March 2019, risankizumab received its first global approval in Japan for the treatment of adults with psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis and erythrodermic psoriasis. Risankizumab has also received approval in the USA, Canada and the EU for the treatment of moderate-to-severe plaque psoriasis, and is in phase 3 development for this indication as well as psoriatic arthritis in several countries worldwide. Phase 2 and 3 clinical evaluation of risankizumab is ongoing in several countries in the treatment of Crohn’s disease and ulcerative colitis. Risankizumab is also in phase 2 development for the treatment of atopic dermatitis globally. This article summarizes the milestones in the development of risankizumab leading to this first approval for psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis and erythrodermic psoriasis.

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Correspondence to Kate McKeage.

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The preparation of this review was not supported by any external funding.

Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Kate McKeage and Sean Duggan are contracted employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

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This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

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McKeage, K., Duggan, S. Risankizumab: First Global Approval. Drugs 79, 893–900 (2019). https://doi.org/10.1007/s40265-019-01136-7

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