Calliditas Therapeutics has received US Food and Drug Administration (FDA) approval for Tarpeyo (budesonide) delayed-release capsules to treat adult primary immunoglobulin A nephropathy (IgAN) patients.
The treatment is indicated for reducing kidney function loss in IgAN patients at risk of disease progression.
The clearance comes after the company filed a supplemental new drug application with the FDA for complete approval of Tarpeyo in June 2023.
In December 2021, Tarpeyo received approval under an accelerated process, based on the surrogate proteinuria marker.
The latest development is based on a kidney function measure.
The regulatory authority granted the approval based on findings from the randomised, double-blind, multicentre Phase III NefIgArd clinical trial of Tarpeyo in primary IgAN patients.
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The trial analysed the safety and efficacy of a 16mg once-a-day dose of the treatment compared to a placebo.
Tarpeyo was found to be well-tolerated. Peripheral oedema, hypertension, muscle spasms, acne and headache were the most frequently seen adverse reactions in the trial.
A B-cell immunomodulator, Tarpeyo acts on the source of disease, reducing the pathogenic galactose-deficient IgA1 antibody production which leads to IgAN.
Calliditas Therapeutics CEO Renee Aguiar-Lucander stated: “We are thrilled that adult IgAN patients at risk for progression in the United States can now have access to this pioneering treatment option that could help preserve their kidney function and, hence, impact the progression of their disease.
“This medicine was specifically developed to target an underlying cause of IgAN, and I would like to express my gratitude to the Calliditas team, study investigators, and most importantly, the patients and caregivers who made this significant milestone possible.”
In July 2022, the company received conditional marketing authorisation from the European Commission for Kinpeygo to treat primary IgAN in adults.
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