CHRONIC KIDNEY DISEASE DRUGS MARKET ANALYSIS

Key Developments

• On August 8, 2024, Novartis announced that the FDA had granted accelerated approval for Fabhalta (iptacopan), a first-in-class complement inhibitor, for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. Fabhalta targets the alternative complement pathway, which is implicated in IgAN when overactivated in the kidneys.
• In July 2024, Ardelyx, Inc., in partnership with the American Association of Kidney Patients and the National Minority Quality Forum, had filed a lawsuit against the U.S. Department of Health and Human Services and CMS. The lawsuit challenges CMS’s plan to include XPHOZAH (tenapanor) and other oral phosphate-lowering therapies in the end-stage renal disease prospective payment system, arguing it will adversely affect patient access to these crucial medications.
• In July 2024, Renalys Pharma initiated its Phase III clinical trial for sparsentan in Japan, targeting IgA nephropathy. The trial, which is a multicenter, open-label study involving around 30 Japanese patients, aims to confirm the drug's efficacy and safety. Results are anticipated in the second half of 2025, supporting a potential approval submission to the Pharmaceuticals and Medical Devices Agency (PMDA).
• In June 2024,FibroGen, Inc. announced that the FDA had cleared its Investigational New Drug (IND) application for FG-3165, a monoclonal antibody targeting galectin-9 (Gal9) for treating solid tumors with high Gal9 expression. CEO Thane Wettig highlighted the milestone as a key step in advancing their oncology pipeline. FG-3165 has shown anti-tumor activity and good safety in preclinical studies.