FDA grants priority review for full approval of Calliditas' Tarpeyo to slow kidney decline

2023-08-18

临床3期临床结果上市批准优先审批加速审批

Calliditas Therapeutics made the announcement today (August 18) that the FDA has accepted the submission for the supplemental New Drug Application (sNDA) for Tarpeyo – budesonide – delayed release capsules.

Tarpeyo is currently approved under accelerated approval to reduce proteinuria in adults with primary Immunoglobulin A Nephropathy (IgAN) at risk of rapid disease progression.

The Prescription Drug User Fee Act (PDUFA) goal date is December 20 this year (2023).

Slow kidney decline

Renee Aguiar-Lucander, CEO of Calliditas, 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 sNDA is based on the full data set from the phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study evaluating the efficacy and safety of the drug (developed under the project name Nefecon) at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized Renin-angiotensin system inhibitors (RASi) RASi therapy. RASi inhibitors RASi inhibitors, specifically angiotensin converting enzyme inhibitor or angiotensin 2 receptor blockers decrease proteinuria and slow the progressive loss of kidney function.

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Significant benefit of Nefecon

Calliditas said the trial showed a statistically significant benefit of Nefecon over placebo in estimated glomerular filtration rate (eGFR) over the two-year study period made up of nine months treatment with Nefecon or placebo. This was followed by a 15-month follow-up period off the study drug.

The data reflected treatment benefits across the entire study population regardless of UPCR baseline and showed a difference between Tarpeyo and placebo in two-year sGFR total slope of approximately 3mL/min per year using a robust regression method of analysis.

“We take great pride in the strong clinical evidence we have gathered, which we believe demonstrates Tarpeyo's durable and clinically meaningful impact on kidney function in the treatment of IgAN,” said Richard Phillipson, Chief Medical Officer at Calliditas.

“The combination of the significant eGFR benefit and the reduction in proteinuria lasting for the entire 15-month follow-up period in the full results of our phase 3 study provide strong rationale for establishing Tarpeyo as the standard of care for IgAN patients.”

Calliditas is also collaborating with its European commercial partner, STADA Arzneimettel AG, to seek full approval of Nefecon Nefecon (which received conditional approval under the brand name Kinpeygo) by the European Commission in the full study population.

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