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Tuesday, January 12, 2021

Bayer Gets FDA Priority Review for Finerenone in Diabetes With Chronic Kidney Disease


Bayer AG on Tuesday said the U.S. Food and Drug Administration granted priority review to finerenone for patients with chronic kidney disease and type 2 diabetes.

The Leverkusen, Germany, chemical and pharmaceutical company said finerenone offers a potential new strategy to delay the progression of chronic kidney disease in people with type 2 diabetes while reducing the risk of cardiovascular events.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.

Bayer said there is currently a significant unmet medical need for the nearly 40% of people in the U.S. with type 2 diabetes who will develop chronic kidney disease, a progressive condition can lead to kidney damage and eventual failure.

https://www.marketscreener.com/quote/stock/BAYER-AG-436063/news/Bayer-Gets-FDA-Priority-Review-for-Finerenone-in-Diabetes-With-Chronic-Kidney-Disease-32177953/

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