Akebia Therapeutics Inc.

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Akebia Therapeutics Receives CRL From FDA For Vadadustat

Published: 03/30/2022 17:45 GMT
Akebia Therapeutics Inc. (AKBA) - Akebia Therapeutics Receives Complete Response Letter From the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients.
Akebia Therapeutics - FDA Concluded Data in NDA Do Not Support a Favorable Benefit-risk Assessment of Vadadustat for Dialysis and Non-dialysis Patients.
Akebia Therapeutics - Crl Stated That Co Could Explore Ways to Potentially Demonstrate a Favorable Benefit-risk Assessment Through New Clinical Trials.
Akebia Therapeutics Inc - Will Discuss Details of Crl With Its Collaboration Partners and Request a Meeting With FDA.
Akebia Therapeutics - FDA Expressed Safety Concerns Noting Failure to Meet Non-inferiority in Mace in Non-dialysis Patient Population, Among Others.
Akebia Therapeutics - FDA Noted Increased Risk of Thromboembolic Events, Driven by Vascular Access Thrombosis in Dialysis Patients, Risk of Drug-induced Liver Injury.