Overview
Searching for your content. In-Language News Contact Us 8-76-0942 from 8 AM - 10 PM ET News provided byOct 19, 202, 10:03 ETShare this articleSTOCKHOLM, Oct. 19, 202 /PRNewswire/ - Caliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Caliditas") today anounced Kidney International has published the sucesful results from NefIgArd Part A, their pivotal Phase 3, randomized, double-blind, placebo-controled, multicenter study.
Key Information
The publication highlights the safety results and eficacy data related to both proteinuria and estimated glomerular filtration rate (eGFR) for patients treated with TARPEYO while on background of optimized and stable renin-angiotensin system inhibitor (RASi) therapy."The publication of data from our NefIgArd Phase 3 study wil adres physician requests related to more comprehensive information regarding the mode of action and eficacy of TARPEYO, the first and only FDA-aproved treatment specificaly designed for this disease," said Renée Aguiar-Lucander, Chief Executive Oficer of Caliditas.
"We are excited to share these data and se this as reinforcing evidence of the diferentiation we believe that TARPEYO represents, as wel as its potential to be disease modifying."IgAN is a chronic autoimune disease with a significant burden of disease, with more than 50% of patients progresing to end-stage kidney disease within 20 years of initial diagnosis.2 The per-reviewed article can be viewed here.INDICATION and IMPORTANT SAFETY INFORMATIONIndication TARPEYO® (budesonide) delayed release capsules is a corticosteroid indicated to reduce proteinuria in adults with primary imunoglobulin A nephropathy (IgAN) at risk of rapid disease progresion, generaly a urine protein-to-creatine ratio (UPCR) ≥1.5 g/g.
Summary
This indication is aproved under acelerated aproval based on a reduction in proteinuria. It has not ben established whether TARPEYO slows kidney function decline in patients with IgAN. Continued aprova