Calliditas pushing for Nefecon/Tarpeyo approval based on NefIgArd data
Swedish biopharma Calliditas Therapeutics (Nasdaq: CALT) continues to press for full approval of Nefecon/Tarpeyo (budesonide) delayed release capsules/Kinpeygo.
The delayed-release formula won accelerated approved in the USA for people with the rare condition IgA nephropathy (IgAN) at the end of 2021. Also known as Berger’s disease, IgAN is as progressive and chronic autoimmune disease that attacks the kidneys.
"A differentiated and disease-modifying treatment alternative"This approval was based on a reduction in proteinuria, with the US Food and Drug Administration (FDA) reserving a full nod pending proof the therapy can slow kidney function decline.
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