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The US FDA has accepted sNDA of Kerendia (finerenone) for the treatment of adults with chronic kidney disease (CKD) without diabetes
sNDA was supported by the P-III (FIND-CKD) trial assessing Kerendia (10 or 20mg) vs PBO, both on top of maximum tolerated labeled doses of a RAS-blocking therapy, in >1,500 adults with non-diabetic CKD
Trial showed slowed kidney disease progression, reducing the annual eGFR decline by 0.7 mL/min/1.73 m²/year over 32mos. It also reduced the risk of the key CV-kidney composite outcome by 23%, with other 2EPs supporting its overall positive profile
Ref: Businesswire | Image: Bayer | Press Release
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The post Bayer Reports US FDA sNDA Acceptance for Kerendia to Treat Non-Diabetic CKD appeared first on PharmaShots.
Bayer Reports US FDA sNDA Acceptance for Kerendia to Treat Non-Diabetic CKD | PharmaVoice