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The Next Chapter In IgAN’s ‘Beautiful Story’ Could Be Full Approval

 
• By Bridget Silverman

US FDA lauds collaborative development of surrogate endpoint that allowed for accelerated approval of the first two drugs for the rare kidney disease. The program was presented as an example of novel endpoints for rare diseases at a Duke/FDA workshop.

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• Source: Shutterstock

The surrogate endpoint that propelled the first two therapies for the rare kidney disease IgA nephropathy will now be stress-tested in the US FDA’s review of Calliditas Therapeutics AB’s recently submitted application to convert the accelerated approval of Tarpeyo to full approval.

Calliditas announced the sNDA submission on 21 June 2023, about two weeks after the development of reduction in proteinuria as a surrogate endpoint in IgAN was presented as a case study at a Duke Margolis Center for Health Policy/FDA workshop on

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