Swedish firm breaking new ground in rare kidney condition
Stockholm’s Calliditas Therapeutics (Nasdaq: CALT) has completed its US regulatory submission for Nefecon (budesonide), an oral treatment for primary IgA Nephropathy (IgAN).
The Swedish firm is seeking an Accelerated Approval from the Food and Drug Administration for the novel formulation, which targets down regulation of IgA, and plans to submit for European marketing authorization imminently.
The European Medicines Agency has indicated that it would be open to reviewing a submission under the similar Conditional Marketing Authorization scheme, based on the firm’s trial program.
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