The supplemental New Drug Application is based on results from the landmark EMPA-KIDNEY phase III trial
OxemiaTM (Desidustat) is an oral tablet formulation that is the first-in-India alternative to injectable erythropoietin-stimulating agents (ESAs)
The NDA for Desidustat is based on positive data from the DREAM-ND and DREAM-D Phase 3 trials in patients with Chronic Kidney Disease (CKD) Not on Dialysis and Dialysis
Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options
Deceased donor kidney transplants are time-critical, and it is uncommon to attempt them robotically
Both companies will promote, market and distribute Sodium Zirconium Cyclosilicate in India under different brand names
The expanded approval allows Kerendia to be prescribed to heart failure patients with a LVEF of 40% or more
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
The new algorithm will be introduced as part of Roche’s CKD Algorithm Panelon thenavify Algorithm Suite
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