Fierce Pharma December 20, 2023
Two years after securing an accelerated approval for its primary immunoglobulin A nephropathy (IgAN) therapy Tarpeyo (budesonide), Calliditas Therapeutics has scored a full FDA endorsement for the oral, delayed-release drug.
Tarpeyo becomes the first treatment fully approved in the United States specifically for the chronic autoimmune kidney condition, also known as Berger’s disease.
While some graduations from accelerated to full approval are ceremonial, this endorsement carries extra weight as it expands the label for Tarpeyo, allowing it to be accessed by all patients with IgAN. Perviously, the FDA limited the med’s use to those at risk for rapid disease progression.
The expansion was facilitated by a confirmatory trial, which was the first phase 3 IgAN study to show significant improvement...
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