The EC granted conditional marketing authorisation for Kinpeygo based on the efficacy and safety data from Part A of the currently ongoing Phase 3 NeflgArd study in adult patients with primary immunoglobulin-A nephropathy
EC approves Kinpeygo to treat primary IgA nephropathy. (Credit: Brett Jordan on Unsplash)
Everest Medicines and its partner Calliditas Therapeutics have secured the European Commission (EC) conditional marketing authorisation (CMA) for Kinpeygo to treat a type of nephropathy in adults.
The drug is indicated for primary immunoglobulin-A nephropathy (IgAN) in adults, who are at risk of disease progression with a urine protein-to-creatinine ratio (UPCR) greater than 1.5g/gram.
IgAN is a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).
Kinpeygo is the first and only approved treatment for IgAN in Europe, said Calliditas.
The current EC authorisation is valid in all 27 member states of the European Union (EU), along with Iceland, Norway and Liechtenstein.
Calliditas intends to transfer the marketing authorization for Kinpeygo to its partner STADA, to roll out Kinpeygo in the European Economic Area (EEA) in the second half of this year.
Calliditas CEO Renée Aguiar-Lucander said: “We are excited to receive the formal approval of Kinpeygo in the EEA as the first and only EMA-approved medication for this disease. We look forward to continuing to work with our European partner, Stada, as they prepare for commercialisation.”
The EC granted CMA for Kinpeygo based on the efficacy and safety data from Part A of the currently ongoing Phase 3 NeflgArd study in adult patients with primary IgAN.
In the study, patients taking Kinpeygo once daily for nine months experienced a statistically significant reduction of 31% proteinuria from baseline compared to 5% for the placebo.
Post nine months, Kinpeygo showed a statistically significant and clinically relevant treatment benefit of 7% on eGFR compared to placebo.
Earlier this year, Everest announced that the findings from the study in a Chinese subpopulation were consistent with top-line results from Part A of the NefIgArd study.
Developed under the name Nefecon, Kinpeygo is an oral, delayed release formulation of budesonide, with enteric coating to delay its release into the distal ileum.
Budesonide is a corticosteroid with potential glucocorticoid activity and weak mineralocorticoid activity that endures a substantial first-pass metabolism.
In June 2019, Everest Medicines signed an exclusive license agreement with Calliditas for the rights to develop and market the drug in Mainland China, Hong Kong, Macau, Taiwan and Singapore.
Earlier this year, the company extended the agreement to include South Korea.
Everest Medicines CEO Kerry Blanchard said: “We congratulate our partner Calliditas for making another major achievement to bring this first-in-disease therapy to more patients globally living with the chronic condition.
“Primary IgAN is more common in Asia than elsewhere in the world with even higher unmet demand for innovative treatment and we hope to make this important therapy available in our region soon.”
Furthermore, Everest Medicines intends to use the study data to submit a New Drug Application in China in the second half of this year.