Calliditas Eyes Full Approval For Tarpeyo In IgAN After Positive Pivotal Update
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.
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The Swedish biotech’s immunoglobulin A nephropathy therapy Tarpeyo is still selling well but “market access friction” is slowing growth. As US regulators grant a priority review to its data package for full approval, Calliditas’s prospects look promising.
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