Additional Relevant Details
The Committee voted no on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks.“We are disappointed with today’s outcome of the Committee’s vote regarding bardoxolone, an investigational drug with a novel mechanism of action,” said Warren Huff, Reata’s President and Chief Executive Officer. “We believe the scientific evidence supports bardoxolone approval in the U.S. for CKD in patients with Alport syndrome, which is one of the most rapidly progressive forms of CKD. We will continue to work with the FDA to answer any questions they may have.”While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision. Reata will continue to work closely with the agency to provide additional information and data until the upcoming Prescription Drug User-Fee Act (“PDUFA”) date of February 25, 2022.