Calliditas plans to file for full approval for rare kidney disease drug following PhIII data
Calliditas believes Phase III confirmatory data it released Sunday for its oral steroid to treat a rare kidney disease could be the final piece needed to get full approval from the FDA.
The trial studied Nefecon, the biotech’s delayed-release budesonide capsules marketed as Tarpeyo, on primary IgA nephropathy (IgAN) patients who were also on a RAS inhibitor therapy. Tarpeyo scored accelerated approval from the agency in December 2021 and conditional marketing authorization from the European Commission in July 2022.
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