Akebia: Vadadustat Trial Achieves Efficacy Endpoints; Fails To Meet Primary Safety MACE Endpoint

(RTTNews) - Akebia Therapeutics, Inc. (AKBA) reported top-line results from its PRO2TECT Global phase 3 program of Vadadustat for treatment of Anemia due to chronic kidney disease in adult patients not on dialysis. Vadadustat achieved the primary and key secondary efficacy endpoint in each of the two PRO2TECT studies, demonstrating non-inferiority to darbepoetin alfa. However, Vadadustat did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events.

The company plans to submit to the FDA a New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease in adult dialysis-dependent and non-dialysis dependent patients as early as possible in 2021. Akebia and its collaborator, Otsuka Pharmaceutical, are working in close collaboration to prepare a Marketing Authorization Application for submission to the European Medicines Agency.

Shares of Akebia Therapeutics were down 70% in pre-market trade on Thursday.