The sNDA is supported by the full data set from the Phase 3 randomised, double-blind, multicenter NefIgArd clinical trial in which Tarpeyo showed a statistically significant benefit over placebo
A picture of immunostaining for IgA in a patient. (Credit: Lazarus Karamadoukis, Linmarie Ludeman and Anthony J Williams from Wikimedia Commons)
Swedish biopharma company Calliditas Therapeutics has secured the priority review from the US Food and Drug Administration (FDA) for the full approval of Tarpeyo (budesonide) for the treatment of immunoglobulin A nephropathy (IgAN).
The FDA granted priority review after accepting the submission for the supplemental New Drug Application (sNDA) for Tarpeyo delayed release capsules.
Tarpeyo delayed release capsules is a corticosteroid, which has FDA accelerated approval to minimise proteinuria in adults with primary IgAN. It is indicated for patients who are prone to fast disease progression and with a urine protein-to-creatinine ratio (UPCR) of ≥1.5g/g.
According to Calliditas Therapeutics, the Prescription Drug User Fee Act (PDUFA) goal date is 20 December 2023.
The sNDA for full approval is supported by the complete data set from the Phase 3 randomised, double-blind, multicentre NefIgArd clinical trial.
The late-stage trial assessed the efficacy and safety of Tarpeyo at a once-daily dose of 16mg, against placebo in adults having primary IgAN who are on optimised RASi therapy. The drug is being developed under the project name Nefecon.
According to the findings, the trial showed a statistically significant benefit of Nefecon over placebo in estimated glomerular filtration rate (eGFR) over the two-year study period.
The study included nine months of treatment with delayed release capsules or placebo, followed by a 15-month follow-up period off the investigational drug.
The pharmaceutical company said that the results were consistent across the entire study population, regardless of UPCR baseline.
Calliditas Therapeutics CEO Renee Aguiar-Lucander said: “We are delighted to have been granted priority review by the FDA, which brings us one step closer to hopefully being able to provide Tarpeyo to all patients at risk of progression and provide physicians with a tool to target the source of this disease to slow kidney function decline.
“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.”
The company is also collaborating with STADA Arzneimettel, its European commercial partner, to seek full approval of Nefecon by the European Commission.
Additionally, Everest Medicines announced that the China National Medical Products Administration (NMPA) accepted the sNDA for Nefecon and has granted priority review. The final decision on the full approval by the Chinese regulator is expected in December 2023.
Everest Medicines has a royalty-bearing license agreement in place with the Swedish firm to develop and commercialise Nefecon in Mainland China, Hong Kong, Macau, Taiwan, Singapore, and South Korea.