Everest, Calliditas Win First Approval for Rare Kidney Disease Drug in Europe
Shanghai-based Everest Medicines has announced the European approval of its rare kidney drug, Kinpegyo. Approval was granted to Everest’s partner, Calliditas Therapeutics, a Swedish biopharma. Developed under the name Nefecon, the drug will be used to treat primary immunoglobulin A (IgA) in nephropathy (IgAN) in high-risk adults with urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.
Kinpegyo, an orphan medicine, is the first Europe-approved treatment for IgAN, a rare, progressive autoimmune kidney disease. 50% of patients with this condition may progress to end-stage renal disease.
The conditional approval will cover all 27 European Union member states as well as Iceland, Norway, and Liechtenstein.
Related article: Everest Medicines Secures Breast Cancer Drug Approval in China
Current and Pending Approvals for Kinpegyo (Nefecon)
The European approval is based on data from the first part of Everest and Calliditas’ pivotal Phase 3 study, NeflgArd. The trial assessed a 16mg, once daily oral dose of Kinpegyo versus placebo in adult primary IgAN patients, and met its primary endpoint in reducing UPCR levels after 9 months of treatment.
Last December, Nefecon was granted FDA accelerated approval under the brand name Tarpeyo. More recently this April, Everest reported that the drug reduced UPCR and stabilized the eGFR in a Chinese subpopulation in line with the pivotal trial results. The new data will be included in a planned filing for approval of the drug in China in the second half of this year.
Everest is also pursuing development and commercialization of Nefecon in Singapore and South Korea, where besides kthe Greater China region, it has exclusive rights.
“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,” commented Kerry Blanchard, MD, PhD, CEO of Everest Medicines.
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