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Calliditas Eyes Full Approval For Tarpeyo In IgAN After Positive Pivotal Update

 
• By Ayisha Sharma

Data from part B of the Swedish firm’s pivotal trial of Tarpeyo in the rare kidney disorder showed that the treatment effects lasted two years across the entire population, enabling the move from conditional to full approvals in several markets.  

Two kidney shapes made out of water, concept of glomerular filtration
Tarpeyo Was Efficacious Across The Entire Trial Population • Source: Shutterstock

Calliditas Therapeutics AB plans to upgrade from fast-track to full approvals for its IgA nephropathy (IgAN) drug Tarpeyo in the US, EU and UK after the product hit the mark in part B of the pivotal NefIgArd trial, surpassing analyst expectations and adding to its case against competitors.

Tarpeyo (budesonide delayed release) first won US Food and Drug Administration accelerated approval and an EU conditional marketing authorization in 2021 for IgAN based on positive data from part A of NefIgArd

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