Akebia Therapeutics Inc. (AKBA) said Tuesday that it received a written response from the Office of New Drugs or OND of the U.S. Food and Drug Administration (FDA) to Akebia's Formal Dispute Resolution Request regarding the Complete Response Letter (CRL) received in March 2022 for vadadustat.
In Tuesday pre-market trade, AKBA was trading at $1.20 up $0.07 or 6.19%.
The letter from the OND stated the company's appeal was denied; however, the letter provided a path forward for the company to resubmit the new drug application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) for dialysis dependent patients.
The letter addressed issues outlined in the CRL, provided feedback and conclusions on those issues, and outlined information to be included in an NDA resubmission, which did not include the generation of additional clinical data.
The Office of New Drugs suggested that Akebia request a Type A meeting with the Division to ensure alignment on the contents of the NDA resubmission. Akebia plans to request the meeting as soon as possible and expects to resubmit the NDA in the second half of 2023.
Vadadustat is currently approved for use in 33 countries. In April 2023 and May 2023 respectively, the European Commission and the United Kingdom Medicines and Healthcare products Regulatory Agency granted marketing authorization for Vafseo (vadadustat), for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysis.
Also in May 2023, Akebia entered into an exclusive license agreement with Germany-based Medice, granting Medice the rights to market and sell Vafseo in the European Economic Area in addition to the United Kingdom, Switzerland and Australia. A launch of Vafseo is expected in Europe by the end of 2023. Vafseo is marketed in Japan by Mitsubishi Tanabe Pharma Corp.
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