Amgen – Akebia (AK(BA)) Files NDA for Vadadustat for Anemia Due to CKD
Akebia Therapeutics, Inc. AK(BA) announced that it has submitted a new drug application for vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) being developed for the treatment of anemia due to chronic kidney disease (“CKD”) in adult patients regardless of whether they are on dialysis or not.
Per the FDA’s standard review timelines, the regulatory body has a 60-day period to decide whether the NDA is complete and acceptable for review.
In October 2020, Akebia completed a pre-NDA meeting with the FDA for vadadustat.
Shares of Akebia have rallied 10.5% so far this year against the industry’s decrease of 3.1%.
We remind investors that, in September 2020, Akebia announced top-line results from the second study of its two phase III cardiovascular outcomes programs — collectively called PRO2TECT– on vadadustat. The studies evaluated the efficacy and safety of vadadustat compared to Amgen’s AMGN Aranesp for the treatment of anemia due to CKD in adult patients who are not receiving dialysis.
Notably, vadadustat is also being evaluated in two other phase III studies, namely INNO2VATE, for the treatment of anemia due to CKD in adult patients who are on dialysis. Last May, the company reported positive top-line data from the same.
The company has successfully completed the INNO2VATE and PRO2TECT program on vadadustat.
Please note that vadadustat is currently approved in Japan and is marketed under the trade name Vafseoas– an oral treatment of anemia due to CKD in adult patients, irrespective of whether they are on dialysis or not.
We note that vadadustat may face competition upon potential approval from the already approved drugs for anemia in CKD patients. Apart from Amgen’s Epogen and Aranesp, Johnson & Johnson’s Procrit and Eprex are approved for the given indication. Besides, several other companies, including FibroGen FGEN and GlaxoSmithKline GSK, are developing candidates with similar mechanism.
Akebia currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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