CAMBRIDGE, Mass., April 28, 2021 /PRNewswire/ -- Akebia
Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with
the purpose to better the lives of people impacted by kidney
disease, today announced that the New England Journal of
Medicine (NEJM) has published the results of the global
Phase 3 clinical program of vadadustat for the treatment of anemia
due to chronic kidney disease (CKD) in adult patients on dialysis
(INNO2VATE) and adult patients not on dialysis
(PRO2TECT) in two separate manuscripts.
Vadadustat, an investigational oral hypoxia-inducible factor
prolyl hydroxylase inhibitor (HIF-PHI), is Akebia's lead product
candidate. In late March 2021, the
Company submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for vadadustat for the treatment of
anemia due to CKD in both adult patients on dialysis and adult
patients not on dialysis.
"Having recently submitted our NDA for vadadustat, we are proud
to have the results of our global Phase 3 clinical program
published in the prestigious New England Journal of Medicine
for review by the broader medical community," said Steven K. Burke, M.D., Chief Medical Officer of
Akebia Therapeutics. "The publications, authored by members of the
independent Executive Steering Committee in collaboration with
trial investigators and Akebia, are a testament to the work of
these team members who designed this program after extensive
dialogue with the FDA and European regulators. We extend our
deepest appreciation to everyone involved in this program,
including the physicians, investigators, site coordinators, and,
most importantly, the nearly 7,500 patients who participated."
"The kidney community has been eagerly awaiting peer-reviewed
publication of comprehensive and straight-forward analyses of
cardiovascular safety and hematological efficacy results of a Phase
3 program evaluating the treatment of anemia associated with CKD
with a novel HIF-PHI," said Glenn
Chertow, M.D., M.P.H., Professor of Medicine at Stanford University School of Medicine, lead author
of one of the manuscripts and Co-Chair of the independent Executive
Steering Committee for the vadadustat global Phase 3 program. "We
are honored to have vadadustat's global Phase 3 clinical program
published in the New England Journal of Medicine. These
publications reflect the clinical relevance, scientific rigor and
transparency of the vadadustat development program."
Kai-Uwe Eckardt, M.D., Professor
of Medicine and Head of the Department of Nephrology and Medical
Intensive Care at the Charité in Berlin,
Germany, and Co-Chair of the independent Executive Steering
Committee for the vadadustat global Phase 3 program, is the lead
author of the INNO2VATE manuscript titled, "Safety
and Efficacy of Vadadustat for Anemia in Patients Undergoing
Dialysis." The manuscript states, "Among patients with anemia and
CKD who were undergoing dialysis, vadadustat was noninferior to
darbepoetin alfa with respect to cardiovascular safety and
maintenance of hemoglobin concentrations."
Dr. Chertow is the lead author of the
PRO2TECT manuscript titled, "Vadadustat in Patients
with Anemia and Non-Dialysis-Dependent CKD," which states,
"Vadadustat, as compared with darbepoetin alfa, met the
prespecified noninferiority criterion for hematologic efficacy but
not the prespecified noninferiority criterion for cardiovascular
safety.
The New England Journal of Medicine is recognized as
the world's leading medical journal and website. Published
continuously for over 200 years, NEJM delivers high-quality,
peer-reviewed research and interactive clinical content to
physicians, educators, researchers, and the global medical
community.
About Akebia Therapeutics
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 2007 and is headquartered in Cambridge, Massachusetts. 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 U.S. Food and
Drug Administration (FDA) or any regulatory authority with the
exception of Japan's Ministry of
Health, Labour and Welfare (MHLW). In Japan, 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.
Investor Contact
Kristen K. Sheppard, Esq.
Ir@akebia.com
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SOURCE Akebia Therapeutics