Calliditas Therapeutics (CALT, CALTX) announced positive topline results from its Phase 3 NefIgArd clinical trial demonstrating the efficacy of Nefecon (TARPEYO/Kinpeygo) in patients with primary IgA nephropathy (IgAN). The trial, which included 364 patients, met its primary endpoint, showing a statistically significant improvement in estimated glomerular filtration rate (eGFR) over two years (p 0.0001). Notably, the eGFR was 5.05 mL/min/1.73 m² higher with Nefecon compared to placebo. The trial results support regulatory filings for full approval from the FDA and European Commission, highlighting Nefecon as a key treatment option for IgAN patients.
Calliditas Therapeutics AB (CALT, CALTX) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted Conditional Marketing Authorization for Kinpeygo® to treat primary immunoglobulin A (IgA) nephropathy in adults at risk of rapid disease progression. Kinpeygo is the first approved treatment for this rare kidney disease, affecting over 50% of patients who may progress to end-stage renal disease. The CMA follows the European Commission's approval in July 2022. Calliditas will transfer CMA rights to STADA, which is already commercializing Kinpeygo in Germany since October 2022, improving patient access across Europe.