Everest Medicines announced that our partner Calliditas Therapeutics AB has been granted conditional marketing authorization for Kinpeygo (developed under the name NEFECON) by the European Commission 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.
In Europe, Kinpeygo is an orphan medicinal product and the first and only approved treatment for IgAN, 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). The conditional marketing authorization applies in all 27 European Union Member States as well as Iceland, Norway and Liechtenstein.
“We are excited to receive the formal approval of Kinpeygo in the European Economic Area as the first and only EMA approved medication for this disease,” said CEO Renée Aguiar-Lucander of Calliditas.
“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,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “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.”
The Kinpeygo approval is 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.
Everest reported in April 2022 that the findings of reduction in proteinuria and stabilization of eGFR in a Chinese subpopulation after 9 months of treatment were in line with topline results from Part A of the NefIgArd study. These data will be included in planned New Drug Application for China in the second half of this year.