Bayer says FDA grants priority review designation for finerenone

Bayer said the U.S. FDA accepted its supplemental New Drug Application for finerenone and granted priority review, a positive regulatory step that can shorten the review timeline. The update supports the drug’s commercial outlook, but it is still only an acceptance for review rather than an approval decision.

Analysis

Bayer said the U.S. FDA accepted its supplemental New Drug Application for finerenone and granted priority review, a positive regulatory step that can shorten the review timeline. The update supports the drug’s commercial outlook, but it is still only an acceptance for review rather than an approval decision.