On September 1, 2022, the FDA approved a supplemental application for the efficacy of Kerendia (finerenone). The supplied record identifies Bayer as the sponsor but does not state a new indication or provide clinical results.
Background
The FDA record identifies the drug as Kerendia, with finerenone as its generic name. It classifies the supplemental application as an efficacy submission. The supplied information does not describe the drug’s class, mechanism, existing indications, or the condition addressed by this application.
What this means
The record confirms FDA approval of a supplemental efficacy application, but it does not specify what efficacy evidence supported the decision or whether the approval changed the drug’s labeled use. Those details cannot be determined from the supplied data.
Source
Source: FDA, Drugs@FDA application overview for NDA 215341, event dated September 1, 2022. Available at accessdata.fda.gov.