Vadadustat fda approval 2021

Vadadustat fda approval 2021 DEFAULT

FDA accepts filing of new drug application for vadadustat

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Akebia Therapeutics Inc. recently announced the FDA accepted its filing of a new drug application for vadadustat for the treatment of anemia in patients with chronic kidney disease.

The FDA assigned a Prescription Drug User Fee Act target action date for the oral hypoxia-inducible factor prolyl hydroxylase inhibitor of March 29, , according to a press release from Akebia.

John P. Butler

“The acceptance of our vadadustat [new drug application] NDA filing marks another important milestone for Akebia and Otsuka [Pharmaceutical Co., Ltd.], as we work to bring a new oral treatment option to patients living with anemia due to CKD,” John P. Butler, CEO of Akebia, said in the release. “We remain confident in the clarity and quality of our data, and we look forward to working with the FDA during their review of our application.”

The NDA is for both patients with end-stage kidney disease on dialysis and for patients with CKD not on dialysis. Last September, Akebia said vadadustat reached primary and key secondary efficacy endpoints in phase 3 PRO2TECT cardiovascular outcomes studies for patients with CKD not on dialysis, but did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority vs. darbepoetin alfa in time to first occurrence of major adverse cardiovascular events.

Akebia and Otsuka are collaborating on the development and commercialization of vadadustat in the United States, Europe, China, Russia, Canada, Australia, the Middle East and certain other territories. In addition, Otsuka is working with Akebia to prepare a marketing authorization application for vadadustat for submission to the European Medicines Agency later this year, according to the release.

 

Sours: https://www.healio.com/news/nephrology//fda-accepts-filing-of-new-drug-application-for-vadadustat

Press Release

, /PRNewswire/ -- , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vadadustat, Akebia's investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease (PRNewsfoto/Akebia Therapeutics, Inc.)

"The submission of the vadadustat NDA for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis marks a significant milestone not only for Akebia and our partners, but also for patients living with this disease," stated , Chief Executive Officer of Akebia. "The Akebia team and our collaborator, Otsuka, did an outstanding job preparing this comprehensive submission, which includes substantial data from over 8, patients across 36 clinical trials of vadadustat. We look forward to working with the FDA during the review process, and are excited to continue collaborating with our partners to advance vadadustat for the benefit of patients, subject to regulatory approval."

Based on standard FDA review timelines, the FDA has a day period to determine whether the NDA is complete and acceptable for review. The Company's NDA submission did not include a Priority Review Voucher.

(Otsuka) is working in close collaboration with Akebia to prepare a Marketing Authorization Application (MAA) for vadadustat for submission to the (EMA), expected this year.

About Akebia Therapeutics 
, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in and is headquartered in . For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH)
inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat recently completed its global Phase 3 clinical development program for the treatment of anemia due to CKD. Vadadustat is not approved by the (FDA) or any regulatory authority with the exception of (MHLW). In , vadadustat is approved and marketed under the tradename Vafseo™, as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

About Anemia due to Chronic Kidney Disease (CKD)
Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person's quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.

Forward-Looking Statements 
Statements in this press release regarding Akebia's strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of , as amended, including, but not limited to, statements regarding: the potential for obtaining approval of vadadustat for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis; the impact of the vadadustat NDA submission on Akebia, its partners and patients living with anemia due to CKD; the exact timing of the confirmation as to whether the NDA is complete and acceptable for review; and the timing of submission of an MAA for vadadustat to the EMA. The terms "expect," "continue," "look forward," "will," and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Annual Report on Form K for the year ended December 31,  and other filings that Akebia may make with the and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Investor Contact: 
, Esq. 
[email protected]

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SOURCE

Sours: https://ir.akebia.com/news-releases/news-release-details/akebia-submits-new-drug-application-nda-fda-vadadustat-treatment
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Otsuka and Akebia Announce U.S. FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease

June 1,

Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Akebia Therapeutics, Inc., announce that the U.S. Food and Drug Administration (FDA) accepted for filing the New Drug Application (NDA) for vadadustat for the treatment of anemia due to chronic kidney disease (CKD) in both adult patients on dialysis and adult patients not on dialysis.

The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of March 29,

Otsuka and Akebia are collaborating on the development and commercialization of vadadustat in the U.S., Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories.

In addition, Otsuka is working with Akebia to prepare a Marketing Authorization Application for vadadustat for submission to the European Medicines Agency expected in

Akebia, founded in and headquartered in Cambridge, Massachusetts.is a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease.

About Vadadustat

Akebia's vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues.

Vadadustat recently completed its global phase 3 clinical development program for the treatment of anemia due to CKD.

About Anemia due to Chronic Kidney Disease

Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person's quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.


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