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The new PDUFA date for Nefecon will be December 15, 2021.
A potential application for Nefecon, a potential treatment for treatment of immunoglobulin A nephropathy (IgAN) has been delayed an additional 2 months.
The US Food and Drug Administration (FDA) announced they would be extending the Prescription Drug User Fee Act (PDUFA) date for Calliditas Therapeutic’s New Drug Application for accelerated approval until December 15. The PDUFA was originally set for September 15.
The application was based on the results from Part A of the HeflgArd phase 3 trial testing the treatment in 200 adult patients with IgAN in which the investigators achieved the primary endpoint of proteinuria reduction compared to placebo while stabilizing the estimated glomerular filtration rate (eGFR) at 9 months.
The FDA has requested more analyses from the NeflgArd trial as a major amendment to the NDA. The request centers on the need for additional eGFR and other related analyses to further support the proteinuria data.
"Our NDA for Nefecon is the first time that the FDA is considering an approval on the basis of proteinuria as a surrogate endpoint for accelerated approval in IgA nephropathy, requiring an in-depth review process,” Renée Aguiar-Lucander, CEO at Calliditas, said in a statement. “We will continue to cooperate closely with the FDA as they complete the review of our NDA”
Also included in the accelerated application is data from the phase 2 NEFIGAN trial, where investigators also met the same primary and secondary endpoints for the chronic kidney disease.
IgAN, which can lead to end-stage renal disease, is the result of protein deposits of immunoglobulin A inside the glomeruli in the kidney.