Everest Medicines Announces European Commission Grants Approval of Kinpeygo® for Adults with Primary IgA Nephropathy to our Partner Calliditas Therapeutics
Kinpeygo® (developed as NEFECON) is the first and only EMA-approved treatment for IgAN
Everest Medicines has exclusive development and commercialization rights to NEFECON in Greater China, Singapore and South Korea
SHANGHAI, July 17, 2022 /PRNewswire/ — Everest Medicines (HKEX 1952.HK, “Everest” or the “Company”), today announced that our partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) has obtained conditional marketing authorization for Kinpeygo® (developed as NEFECON) from the European Commission for the treatment of primary immunoglobulin A (IgA) (IgAN) nephropathy in adults at risk of rapid disease progression with a urinary protein to creatinine ratio (UPCR) ≥1.5 g/gram.
In Europe, Kinpeygo is an orphan drug and the first and only approved treatment for IgAN, a rare and progressive autoimmune kidney disease with high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (IRT). The conditional marketing authorization applies in the 27 Member States of the European Union as well as in Iceland, Norway and Liechtenstein.
“We are delighted to receive formal approval for Kinpeygo in the European Economic Area as the first and only EMA-approved medicine for this disease,” said CEO Renée Aguiar-Lucander of Calliditas.
“We congratulate our partner Calliditas for achieving another major achievement in bringing this first disease therapy to more patients around the world living with the chronic disease,” said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. “Primary IgAN is more common in Asia than anywhere else in the world with an even higher unmet demand for an innovative treatment and we hope to make this important therapy available soon in our region. »
Kinpeygo’s approval is based on efficacy and safety data from Part A of the pivotal Phase 3 NeflgArd study, an ongoing multicenter, randomized, double-blind, placebo-controlled study conducted to evaluate Kinpeygo 16 mg once daily orally versus placebo in adult patients with primary IgAN.
Everest reported in April 2022 that the results of reduction of proteinuria and stabilization of eGFR in a Chinese subpopulation after 9 months of treatment were consistent with the main results of part A of the NefIgArd study. These data will be included in the new drug application planned for China in the second half of this year.
NEFECON is a delayed-release oral formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes extensive first-pass metabolism. NEFECON has been designed as a 4 mg delayed release capsule and is enteric coated so that budesonide is released into the distal ileum. In June 2019Everest Medicines has entered into an exclusive, royalty-based license agreement with Calliditas, which gives Everest Medicines the exclusive rights to develop and commercialize NEFECON in mainland China, hong kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 include South Korea as part of the Everest Medicine territories.
About drugs Everest
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address the critical unmet medical needs of patients in Asian markets. Everest Medicines’ management team has deep expertise and extensive experience in high quality clinical development, regulatory affairs, CMC, business development and operations in both China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune diseases, cardio-renal diseases and infectious diseases. For more information, visit their website at www.everestmedicines.com.
Calliditas Therapeutics is a commercial-stage biopharmaceutical company based in Stockholm, Sweden focused on the identification, development and commercialization of new treatments in orphan indications, with an initial focus on kidney and liver diseases with significant unmet medical needs. Calliditas’ lead product, developed under the name Nefecon, obtained accelerated FDA approval under the trade name TARPEYOMT and conditional marketing authorization by the European Commission under the trade name KINPEYGO®.
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SOURCE Everest Medicines