We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Akebia (AKBA) Files NDA for Vadadustat for Anemia Due to CKD
Read MoreHide Full Article
Akebia Therapeutics, Inc. (AKBA - Free Report) 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 - Free Report) 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 - Free Report) and GlaxoSmithKline (GSK - Free Report) , are developing candidates with similar mechanism.
With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
Image: Bigstock
Akebia (AKBA) Files NDA for Vadadustat for Anemia Due to CKD
Akebia Therapeutics, Inc. (AKBA - Free Report) 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 - Free Report) 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 - Free Report) and GlaxoSmithKline (GSK - Free Report) , are developing candidates with similar mechanism.
Zacks Rank
Akebia currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5G Revolution: 3 Stocks to Make Your Move
With super high data speed, it will make current cell phones obsolete and unlock the full potential of big data, cloud computing, and artificial intelligence. In the next few years this industry is predicted to create 22 million jobs and a stunning $12.3 trillion in revenue.
Today you have an historic chance to pursue almost unimaginable gains like Microsoft, Netflix, and Apple in their early phases. Zacks has released a Special Report that reveals our . . .
Download now. Today the report is FREE >>