Calliditas wins full approval for steroid drug in rare autoimmune disease
Calliditas Therapeutics converted its accelerated approval for Tarpeyo in primary immunoglobulin A nephropathy (IgAN) to a full approval, marking what it says is an important milestone for patients with the rare autoimmune disease.
IgAN is a chronic disease that attacks the kidneys and is also called Berger’s disease. Tarpeyo, a delayed-release formulation of the steroid budesonide, was first approved in 2021 to reduce proteinuria (increased protein levels in the urine) in patients at risk of rapid disease progression. The full approval broadens the drug’s label to include all adults at risk of disease progression.
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