The US Food and Drug Administration (FDA) has accepted Calliditas Therapeutics’ supplemental New Drug Application (sNDA) submission and granted priority review for full approval of TARPEYO (budesonide) delayed release capsules to treat IgA nephropathy (IgAN).
The regulator has provided the Prescription Drug User Fee Act (PDUFA) date of 20 December this year for the review.
Currently approved under accelerated approval, TARPEYO is developed under the project name Nefecon.
It was found to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) of ≥1.5g/g.
The sNDA is based on results from the multicentre, double-blind, randomised Phase III NefIgArd clinical trial.
The two-year study compared the safety and efficacy of 16 mg TARPEYO against placebo in patients with primary IgAN and are on optimised RASi therapy.
They received once-daily dose of TARPEYO and placebo for nine months and were then followed for 15 months.
Nefecon demonstrated benefit over placebo (p-value < 0.0001) in estimated glomerular filtration rate (eGFR).
The regression method of analysis data also showed a difference between TARPEYO and placebo in two year eGFR total slope of nearly 3mL/min per year.
Calliditas Therapeutics CEO Renee Aguiar-Lucander said: “The significant eGFR treatment benefit observed across the entire study population provides further evidence that TARPEYO can be disease-modifying, potentially significantly delaying the need for dialysis or kidney transplantation for patients at risk.”
In Europe, Nefecon received conditional approval under the brand name Kinpeygo by the European Commission.
Calliditas is collaborating with its European commercial partner STADA Arzneimettel to seek full approval.