Bayer's Kerendia approved by UK regulator
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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Pharmaceutical
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze