Nefecon is designed for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. IgAN is a disease in which IgA protein builds up in and damages the filtering part of the kidney (glomerulus). The damage may cause few or no symptoms but blood in the urine is the most common symptom.
Treatment is aimed at protecting the kidney from further damage by controlling blood pressure, cholesterol, and inflammation.
China has the highest prevalence of primary glomerular diseases in the world with an estimated five million IgAN patients. There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
Decisions expected in Singapore and Hong Kong
Everest also announced that, in addition to Nefecon’s approval in mainland China and Macau, it expects a decision on New Drug Application (NDA) approval in Singapore and Hong Kong in the near term.
“We are very excited about Nefecon’s approval in China. There is clearly a very significant need amongst IgAN patients in China to have access to an approved medication specifically designed to target the origin of the disease and which provides hope of disease modification,” says CEO Renée Aguiar-Lucander.
During a phase 3 trial called NeflgArd, results from the Chinese subpopulation analysis provided evidence that the treatment effect of Nefecon in the Chinese cohort was greater than in the global data set. This was with regard to kidney function, proteinuria, and microhematuria.
In the Chinese cohort, the mean absolute change from baseline in eGFR at 24 months showed an approximately 66% reduction in loss of this measure of kidney function with Nefecon compared with a 50% reduction in loss of eGFR in the global data set.
Milestone payment of $5 million
This approval triggers a milestone payment of $5 million to Calliditas, which will be included as revenue in the fourth quarter.
Calliditas is a commercial-stage biopharma company based in Sweden focused on identifying, developing, and treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
Its kidney disease drug, Tarpeyo, was granted priority review by the US Food and Drug Administration (FDA) back in August this year (2023). The FDA accepted the submission for the supplemental New Drug Application (sNDA) for Tarpeyo – budesonide – delayed-release capsules.
Tarpeyo under accelerated approval
Tarpeyo is currently approved under accelerated approval to reduce proteinuria in adults with primary Immunoglobulin A Nephropathy (IgAN) at risk of rapid disease progression. It also has conditional marketing authorization from the European Commission under the trade name Kinpeygo.
Nefecon has been granted accelerated approval by the US Food and Drug Administration (FDA) under the trade name Tarpeyo and conditional marketing authorization by the European Commission under the trade name Kinpeygo.
Kinpeygo is being commercialized in the European Union Member States by Calliditas’ partner, STADA Arzneimittel AG. Additionally, Calliditas is conducting a phase 2b clinical trial in primary biliary cholangitis and a phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, setanaxib.