Bayer can report good news from the USA for the drug candidate Finerenone: the FDA has granted the application priority review status, the company said on Tuesday. Finerenone is said to be used to treat patients with chronic kidney disease and type 2 diabetes.
With the priority review, the FDA will decide on the approval of the drug within six months – a period of ten months would be usual.
The background to the priority test is a high unmet medical need in the indication. “Almost 40% of people in the US with type 2 diabetes develop chronic kidney disease. The disease often develops unnoticed. Despite currently available therapies, kidney damage and ultimately kidney failure can occur, ”says Michael Devoy, Head of Medical Affairs & Pharmacovigilance in the Pharmaceuticals Division at Bayer AG and Chief Medical Officer. “Finerenone offers a potential new strategy to prevent further end organ damage, slow the progression of CKD and reduce the risk of cardiovascular events,” said the manager.
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