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Voclosporin: First Approval

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posted on 25.03.2021, 22:21 by Young-A Heo

Declarations


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


Authorship and 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. Young-A Heo is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.


Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable

Additional information about this Adis Drug Review can be found here


Abstract

Voclosporin (Lupkynis) is an oral calcineurin inhibitor immunosuppressant that is being developed by Aurinia Pharmaceuticals. In January 2021, based on positive results from the pivotal phase II and III trials, oral voclosporin received its first approval in the USA for use in combination with a background immunosuppressive therapy regimen for adults with active lupus nephritis. Voclosporin is also being explored for the novel coronavirus disease 2019 (COVID-19) in kidney transplant recipients. This article summarizes the milestones in the development of voclosporin leading to this first approval for lupus nephritis.


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