Biopharmaceutical company Akebia Therapeutics (NASDAQ:AKBA) has received a response for its formal dispute resolution request associated with the complete response letter (CRL) for vadadustat.
In the written response, the Office of New Drugs (OND) denied AKBA’s appeal but provided the company a path to resubmit the new drug application (NDA) for vadadustat for the treatment of anemia in dialysis-dependent patients.
Importantly, the OND has suggested a Type A meeting between the company and the division and AKBA now plans to request a meeting at the earliest and resubmit the NDA in the second half of this year.
Additionally, vadadustat has already bagged approval in 33 countries with a European launch expected by the end of this year.
With today’s price gains, AKBA shares have now gained nearly 93.5% so far this year.
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