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.
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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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