Calliditas Therapeutics has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for complete approval of TARPEYO (budesonide).
The TARPEYO delayed-release capsule is a corticosteroid indicated for reducing proteinuria to treat primary immunoglobulin A nephropathy (IgAN) in adult patients at risk of quick disease progression, generally having a urine protein-to-creatinine ratio greater than or equal to 1.5g/g.
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The therapy received accelerated approval based on showing a reduction in proteinuria.
The submission of sNDA to the regulator was based on the findings obtained from the Phase III NefIgArd clinical trial.
The multicentre, randomised, double-blind trial was designed to evaluate the safety and efficacy of TARPEYO 16 mg compared with placebo against a background of optimised RASi (renin–angiotensin system inhibitor) therapy in primary IgA adult patients.
TARPEYO showed a highly statistically significant benefit in estimated glomerular filtration rate (eGFR) over a two-year period of treatment. The treatment period comprises nine months on TARPEYO or placebo, then 15 months of follow-up.
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By GlobalDataCalliditas Therapeutics CEO Renée Aguiar-Lucander stated: “The eGFR treatment benefit observed across the entire study population, irrespective of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment that holds the promise of being disease-modifying.
“We are pleased to be able to provide the FDA with the full results of our Phase III study, and we look forward to interactions with the FDA regarding full approval of TARPEYO.”
The company is also collaborating with its European commercial partner STADA Arzneimettel to seek complete approval for Nefecon, branded as Kinpeygo, from the European Commission.
