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Stada introduces Kinpeygo in European markets to treat primary IgA nephropathy

Bad Vilbel, Germany
Wednesday, September 21, 2022, 14:00 Hrs  [IST]

Stada has achieved a major milestone in expanding its specialty care business by introducing Kinpeygo (budesonide), in the European Union (EU). Stada has selected Germany as the lead launch market, with launches in additional European countries planned in the future.

Kinpeygo is designated as an orphan medicinal product and is the first and only approved treatment in the EU for primary immunoglobulin A nephropathy (IgAN), a rare, progressive disease of the kidneys with a high unmet need. Within 20 years of diagnosis, more than 25%-30% of patients develop end-stage kidney disease that requires dialysis or kidney transplantation. Introduced through a partnership with developer Calliditas Therapeutics, Kinpeygo will be marketed in the European Economic Area (EEA) exclusively by Stada.

Primary IgAN, also known as Berger’s disease, is a chronic, debilitating and life-threatening kidney disease. It is the most prevalent primary chronic glomerulonephritis worldwide. An orphan disease, IgAN is estimated to affect approximately 200,000 people in the EU and United Kingdom.

“The problem with IgA nephropathy is that most patients do not know that they have this disease, and a large proportion of patients are diagnosed by coincidence,” explained Professor Jonathan Barratt, Mayer Professor of Renal Medicine at the University of Leicester. “There is a significant unmet need in the treatments we can offer our patients.”

In the lead launch market for Kinpeygo, Germany, 3.1 people per 100,000 develop IgAN each year, an incidence somewhat higher than the 2.5 per 100,000 incidence globally. Men are twice as likely as women to suffer from IgAN. The disease is most likely to first manifest itself in the 16-35 years age group.

“Making Kinpeygo available to primary IgAN patients in Europe brings, for the first time, a therapeutic option to an under-served patient population,” commented Stada CEO Peter Goldschmidt. “The launch of Stada’s first orphan Specialty medicine is evidence of how Stada is bringing additional value to patients, healthcare professionals and health systems through a broad portfolio of specialty, generics and consumer healthcare products.“

Budesonide for the treatment of primary IgA nephropathy has since 2016 held a designation as an orphan medicinal product. This designation is for medicines to be developed for the diagnosis, prevention or treatment of rare diseases that are life-threatening or very serious. In the EU, a disease is defined as rare if it affects fewer than 5 in 10,000 people. “A key part of STADA’s mission in Specialty Care is to address under-served patients, including those with rare diseases such as IgAN,“ stated Bryan Kim, Stada’s head of global specialty care, EVP. “While significant investment and time are required to bring these complex medications to a relatively small subset of the population, for the affected patients and their families, therapies such as Kinpeygo can be life-altering.”

In granting a conditional marketing authorization for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) =1.5 g/gram, the European Medicines Agency determined that “Kinpeygo was shown to be effective at lowering the level of excess protein in the urine in patients with IgAN, indicating an improvement in kidney function”.

“Treatment with Kinpeygo was generally well tolerated, and side effects were in line with the known safety profile of budesonide,” the EMA stated.

The conditional marketing authorization for Kinpeygo was based on the efficacy and safety data of Part A of the NeflgArd pivotal phase 3 study, an ongoing, randomized, double-blind, placebo-controlled, multicentre study conducted to evaluate Kinpeygo 16 mg once daily oral dose vs placebo in adult patients with primary IgAN. The effect of Kinpeygo, which was developed under the name Nefecon, was assessed in patients with biopsy-proven IgAN, eGFR =35 mL/min/1.73 m2, and proteinuria (defined as =1 g/day) who were on a stable dose of recommended or maximum tolerated RAS blockade. Patients taking 16mg of Kinpeygo once daily showed a statistically significant 31% reduction in UPCR from baseline vs 5% in the placebo arm after 9 months of treatment. Kinpeygo 16 mg once daily also provided a statistically significant and clinically relevant 7% treatment benefit on eGFR compared to placebo (p=0.0014). In the subgroup of patients with baseline UPCR =1.5g/g, eGFR declined by 10.1 mL/min/1.73 m2 over 12 months of the placebo group of Nef-301. In comparison, eGFR declined by only 1.1 mL/ min/1.73 m2 in the Kinpeygo treatment group, resulting in a difference of 8.98 mL/min/1.73 m2 at 12 months.

A prescription medicine, Kinpeygo contains the corticosteroid budesonide, delivered orally as 4mg delayed-release capsules. Each delayed-release capsule has an enteric coating so that it remains intact until it reaches the ileum section of the small intestine. The recommended dose is 16mg once per day in the morning, at least one hour before a meal, for 9 months, with dose tapering upon discontinuation.

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

 

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