The jab, which is a kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system, was granted a priority review in March 2021. Korsuva will be commercialised globally by Vifor Pharma.
The new drug application (NDA) filing was supported by positive data from two pivotal phase-III trials KALM-1, conducted in the US and the global KALM-2, as well as supportive data from an additional 32 clinical studies.