STADA and Calliditas seek European marketing approval for Kinpeygo to treat primary IgA nephropathy

STADA and Calliditas Therapeutics AB announced the submission of a request to the European Medicines Agency (EMA) for the Committee for Medicinal Products for Human Use (CHMP) to convert the conditional marketing authorization for Kinpeygo, their treatment for primary IgA nephropathy (IgAN), to standard, or “full”, marketing authorization.

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) =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.

Kinpeygo is the first and only approved treatment in Europe for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need. STADA, which holds European commercial rights, already launched the IgAN medicine in Germany in September 2022 and is working to extend patient access to other countries.

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 The Lancet. 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 in adult patients with primary IgAN. The trial met its primary endpoint, with Kinpeygo demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9 months of treatment with Kinpeygo or placebo and 15 months of follow-up off drug.

“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,” commented STADA’s head of global specialty, Bryan Kim.

“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,” stated Renée Aguiar-Lucander, chief executive officer of Calliditas Therapeutics.

Kinpeygo is an oral, modified-release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. Kinpeygo is a 4 mg modified-release capsule and is enteric coated and designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy.

The global clinical trial NefIgArd is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of Kinpeygo 16 mg once daily vs placebo in adult patients with primary IgAN (N=364), as an addition to optimized RAS inhibitor therapy. Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period. The primary endpoint was UPCR, and eGFR was a secondary endpoint. Part B included a 12-month observational period off drug and assessed eGFR over the entire 2-year period for patients who were treated with the Kinpeygo or placebo regimen in Part A. The full NefIgArd trial met its primary endpoint. Topline data from the full NefIgArd study were reported on March 12, 2023.

Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger’s Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney. This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s.

STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma.

Calliditas Therapeutics is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.

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