Bayer's Kerendia approved by UK regulator

9 March 2022

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorized the use of Kerendia (finerenone) (10mg or 20mg) in Great Britain, an oral, first-in-class non-steroidal, selective mineralocorticoid receptor (MR) antagonist, for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.

Developed by German pharma major Bayer, (BAYN; DE), Kerendia was approved in the USA in July 2021 and the European Union (including Northern Ireland) last month, and regulatory filings in other regions are underway or planned. Bayer’s shares were up almost 5% at 52.99 euros by mid-afternoon today.

The authorization is based on the results of the pivotal Phase III FIDELIO-DKD study investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in 5,734 adult patients with CKD associated with T2D, published in the New England Journal of Medicine (NEJM) in October 2020.

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