February 25, 2022
On February 25th, the U.S. Food and Drug Administration (FDA) announced its decision not to approve a New Drug Application for the use of bardoxolone methyl as a treatment for Alport syndrome. Bardoxolone methyl was investigated for safety and efficacy in Alport patients through the CARDINAL Study, the first-ever clinical trial for our rare disease.
Click here for ASF’s Press Release addressing the FDA’s decision.
Click here for a brief video message from Alport Syndrome Foundation’s Executive Director, Lisa Bonebrake, directed to the patient community. A full transcript of the video message can be read at this link.
Questions regarding the FDA decision can be addressed to [email protected].
Further information regarding clinical trials open to Alport syndrome patients can be viewed here.