The request to the EMA will be considered by the committee for medicinal products for human use (CHMP) to convert its existing conditional marketing authorization for Kinpeygo.
Kinpeygo is currently approved under conditional approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) greater than or equal to 1.5 g/gram.
This was granted in the interest of public health because the medicine addresses an unmet medical need, and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required.
Already launched in Germany in September last year (2022) by STADA, which holds European commercial rights, Kinpeygo is the first and only approved treatment in Europe for the rare, progressive autoimmune disease of the kidney with an unmet need. STADA is hoping to launch the treatment in other European countries soon.
STADA’s head of global specialty, Bryan Kim, said: “By filing for a standard marketing authorization with the EMA, based on the full dataset as published in the Lancet journal, STADA and Calliditas are optimistic about bringing this important Specialty therapy for unmet medical need in chronic kidney disease to more people with IgAN in Europe.”.
The submission to the CHMP for full approval is based on the full two-year data set from the phase 3 NefIgArd clinical trial, as recently published in leading medical journal. This randomized, double-blind, multicenter study assessed the efficacy and safety of Kinpeygo - developed under the project name Nefecon - dosed at 16 mg once daily versus placebo on a background of optimized renin-angiotensin system inhibitor (RASi) therapy.
The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo in estimated glomerular filtration rate (eGFR) over the two-year period of nine months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug.
“The eGFR treatment benefit observed across the entire study population, irrespective of UPCR levels, provides further evidence that targeting IgAN at its source can offer patients a treatment that holds the promise of being disease modifying. We are pleased to be able to provide the EMA with the full results of our Phase 3 study, and we look forward to interactions with the regulatory agency regarding full approval of Kinpeygo,” said Renée Aguiar-Lucander, chief executive officer of Calliditas Therapeutics.
In August this year (2023), the US Food and Drug Administration (FDA) accepted submission for the supplemental new drug application (sNDA) and granted priority review for full approval of the same drug, named Tarpeyo. The prescription drug user fee act (PDUFA) goal date is December 20.