-- Analysis Shows Greater Mortality in Patients with
Erythropoiesis-Stimulating Agent Hyporesponse --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company
focused on delivering innovative therapies to patients with kidney
disease through the biology of hypoxia-inducible factor (HIF), today
announced the publication of a retrospective analysis indicating
persistently greater mortality in dialysis-dependent chronic kidney
disease (DD-CKD) patients with erythropoiesis-stimulating agent
hyporesponse (ESAhr). The article, titled "Spectrum and Burden of
Erythropoiesis-Stimulating Agent Hyporesponsiveness Among Contemporary
Hemodialysis Patients," was published online
in the American Journal of Kidney Diseases.
"This large scale analysis shows a persistently greater risk of
mortality among patients who are ESA hyporesponders when compared to
non-hyporesponders," said Brad Maroni, MD, Chief Medical Officer of
Akebia. "In addition, the hyporesponse persisted for more than two
years, during which time patients required higher doses of ESA and iron.
This is the first study of its kind since changes to ESA product
labeling and reimbursement were implemented, and these findings
highlight the need for new treatment options that can effectively manage
patients with ESAhr. We believe that vadadustat may provide a solution
for ESA hyporesponders and look forward to evaluating its potential
benefits in this patient population."
The analysis of over 98,000 patients showed that ESAhr, defined as 2
consecutive hemoglobin measurements < 10 g/dL while receiving an ESA
dose > 7,700 U/treatment, was associated with 1.5-2.5-fold increased
risk of mortality and this association persisted for at least two years
after ESAhr was identified. ESAhr was also associated with lower
hemoglobin levels, greater ESA and iron use, and higher rates of missed
hemodialysis treatment throughout the follow-up period. This study
represents the first analysis of ESAhr since changes to both U.S.ESA
product labeling and reimbursement policy for injectable drugs for
dialysis patients were implemented in 2011, which resulted in marked ESA
dose reductions for the treatment of anemia related to DD-CKD.
The retrospective analysis of data collected during 2012 and 2013 was
conducted in collaboration with DaVita Clinical Research, a wholly-owned
subsidiary of DaVita HealthCare Partners Inc. The dataset contained
information on patient demographics, disease history, comorbidities,
dialysis-specific information for each treatment session, laboratory
results such as hemoglobin, and IV anemia medications administered at
dialysis sessions (ESAs and iron). Patients included in the analysis had
received in-center hemodialysis treatment at a DaVita facility, and had
been receiving dialysis for six months or more to allow for
stabilization of ESA dose following dialysis initiation. The full
manuscript is available on the American Journal of Kidney Diseases
website at: http://www.ajkd.org/article/S0272-6386(16)30282-7/fulltext.
About Anemia Related to Chronic Kidney Disease
Approximately 30 million people in the U.S. have chronic kidney disease
(CKD), with an estimated 1.8 million of these patients suffering from
anemia. Anemia results from the body's inability to coordinate red blood
cell production in response to lower oxygen levels due to the
progressive loss of kidney function, which occurs in patients with CKD.
Left untreated, anemia significantly accelerates patients' overall
deterioration of health with increased morbidity and mortality. Renal
anemia is currently treated with injectable recombinant erythropoiesis
stimulating agents, which are associated with inconsistent hemoglobin
responses and well-documented safety risks.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered
in Cambridge, MA, focused on delivering innovative therapies to patients
with kidney disease through hypoxia-inducible factor biology. Akebia's
lead product candidate, vadadustat, is an oral therapy in development
for the treatment of anemia related to chronic kidney disease in both
non-dialysis and dialysis patients. Akebia has commenced its vadadustat
Phase 3 Program, which includes the PRO2TECT studies for
non-dialysis patients with anemia secondary to chronic kidney disease
and INNO2VATE studies for dialysis dependent patients. For
more information, please visit our website at www.akebia.com.
Forward-Looking Statements
This press release includes forward-looking statements. Such
forward-looking statements include those about Akebia's strategy, future
plans and prospects, including statements regarding the potential
indications and benefits of vadadustat. The words "anticipate,"
"appear," "believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "target," "potential," "will," "would," "could,"
"should," "continue," and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. Each forward-looking statement is
subject to risks and uncertainties that could cause actual results to
differ materially from those expressed or implied in such statement,
including the risk that existing preclinical and clinical data may not
be predictive of the results of ongoing or later clinical trials; the
ability of Akebia to successfully complete the clinical development of
vadadustat; the funding required to develop Akebia's product candidates
and operate the company, and the actual expenses associated therewith;
the cost of the Phase 3 studies of vadadustat and the availability of
financing to cover such costs; the timing and content of decisions made
by the FDA and other regulatory authorities; the rate of enrollment in
clinical studies of vadadustat; the actual time it takes to prepare for
and initiate clinical studies; the success of competitors in developing
product candidates for diseases for which Akebia is currently developing
its product candidates; and Akebia's ability to obtain, maintain and
enforce patent and other intellectual property protection for
vadadustat. Other risks and uncertainties include those identified under
the heading "Risk Factors" in Akebia's Annual Report on Form 10-Q for
the quarter ended June 30, 2016, and other filings that Akebia may make
with the Securities and Exchange Commission in the future. Akebia does
not undertake, and specifically disclaims, any obligation to update any
forward-looking statements contained in this press release.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160822005258/en/
Akebia:
AJ Gosselin, 617-844-6130
Manager, Corporate
Communications
agosselin@akebia.com
Source: Akebia Therapeutics, Inc.
News Provided by Acquire Media