New England Journal of Medicine Publishes Pivotal Trial Data for OMONTYS® (peginesatide) Injection for Treatment of Anemia in Adult Chronic Kidney Disease Patients on Hemodialysis
-- Head-to-Head Comparison of Efficacy of Erythropoiesis-Stimulating
Agents, Including First Prospective Cardiovascular Safety Assessment --
PALO ALTO, Calif. & DEERFIELD, Ill.--(BUSINESS WIRE)--
Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceuticals U.S.A., Inc.
(TPUSA) today announced that pivotal Phase 3 data on the safety and
efficacy of OMONTYS® (peginesatide) Injection were published
in the January 24th issue the New England Journal of
Medicine (NEJM). These studies, known as EMERALD 1 and 2,
compared OMONTYS given once monthly to epoetin administered one-to-three
times per week (according to epoetin product labeling) in the treatment
of anemia in adult chronic kidney disease (CKD) patients on hemodialysis.
The EMERALD studies were part of the New Drug Application (NDA) upon
which the U.S. Food and Drug Administration's (FDA) March 27, 2012
approval of OMONTYS was based. These studies evaluated the use of the
medication in treating one of the common complications of CKD among
dialysis patients. OMONTYS is indicated for the treatment of
anemia due to CKD in adult patients on dialysis. OMONTYS is not
indicated and is not recommended for use in patients with CKD not on
dialysis, in patients receiving treatment for cancer and whose anemia is
not due to CKD, or as a substitute for red blood cell (RBC) transfusions
in patients who require immediate correction of anemia. OMONTYS has not
been shown to improve symptoms, physical functioning, or health-related
quality of life. Please see Important Safety Information including Boxed
The efficacy and cardiovascular (CV) safety assessment data published in NEJM
Noninferiority to Epoetin in Maintenance of Hemoglobin (Hb):
The difference between the OMONTYS and epoetin-treated groups in the
mean change in Hb levels from baseline to the study evaluation period
(calculated as the mean of all measurements during weeks 29-36) in
EMERALD 1 and 2 was -0.15 g/dL (95 percent CI: -0.30, -0.01) and 0.10
g/dL (95 percent CI: -0.05, 0.26) respectively.
Similar Cardiovascular Safety in Hemodialysis Population:
In the EMERALD studies, 22.8 percent of OMONTYS patients experienced
one of the composite cardiovascular events, compared to 24.4 percent
of epoetin patients (hazard ratio for the cardiovascular composite
safety endpoint was 0.95 (0.77, 1.17) (95 percent CI)). OMONTYS
is not indicated in patients with CKD not on dialysis. These patients
experienced increased specific cardiovascular events.
In these studies, the most common adverse events (greater than ≥10%)
were dyspnea, diarrhea, nausea, cough and arteriovenous fistula site
"The EMERALD results are important because they not only evaluated the
efficacy of OMONTYS and epoetin; they also represent data from the first
studies to prospectively compare the cardiovascular safety of different
erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in
dialysis patients with CKD," said Steven Fishbane, M.D., Professor of
Medicine, Hofstra North Shore-Long Island Jewish School of Medicine,
lead author of the NEJM publication, and principal investigator
for the EMERALD studies. "The EMERALD data demonstrated that OMONTYS
administered once a month has a similar efficacy and cardiovascular
safety profile when compared to epoetin administered one-to-three times
About the EMERALD Studies and Cardiovascular Safety Assessment
Approximately 1,600 adult CKD hemodialysis patients across 178 sites in
the U.S. and Europe were evaluated in the EMERALD 1 and 2 trials (1,066
patients received OMONTYS; 542 received epoetin). The primary efficacy
endpoint of these studies was the mean change in Hb from the baseline Hb
level to the mean level during the evaluation period (between weeks 29
through 36). In these trials, CKD patients on hemodialysis who were
stable on epoetin, were randomized to receive OMONTYS either once every
four weeks or to continue treatment with epoetin (according to epoetin
labeling), with the dose adjusted as necessary to maintain Hb levels
within the study-specified range (10.0-12.0 g/dL) for 52 weeks or more.
Current Prescribing Information recommends reducing or interrupting the
dose as Hb levels approach or exceed 11 g/dL.
The EMERALD studies were part of the first Phase 3 program to
prospectively evaluate the CV safety of different ESAs based on a
composite cardiovascular safety endpoint (CSE). The CSE was adjudicated
by a blinded and independent committee. Events included in the CSE
pre-specified analysis were death from any cause, stroke, myocardial
infarction, serious adverse events associated with congestive heart
failure, unstable angina, or arrhythmia.
About Anemia Due to CKD in Adult Patients on Dialysis
Anemia is a complication of CKD and is associated with cardiovascular
illness and mortality. As of 2010, the United States Renal Data System
noted there were more than 410,000 people in the United States who were
About OMONTYS® (peginesatide) Injection
OMONTYS is a synthetic, pegylated ESA. It is the only ESA that is
peptide-based and its building blocks (amino acids) are arranged in a
different order than erythropoietin (i.e., it has no sequence homology
to endogenous erythropoietin).
On March 27, 2012, the United States Food and Drug Administration
approved OMONTYS for the treatment of anemia due to CKD in adult
patients on dialysis. The product is the first ESA to be marketed in the
United States (U.S.) in over 10 years and is the only once-monthly ESA
for anemia available to this patient population in the United States.
IMPORTANT SAFETY INFORMATION
WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION,
STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR
PROGRESSION OR RECURRENCE.
Chronic Kidney Disease:
In controlled trials, patients experienced greater risks for death,
serious adverse cardiovascular reactions, and stroke when administered
erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level
of greater than 11 g/dL.
No trial has identified a hemoglobin target level, ESA dose, or
dosing strategy that does not increase these risks.
Use the lowest OMONTYS dose sufficient to reduce the need for RBC
OMONTYS is contraindicated in patients with uncontrolled hypertension
and in patients who have had serious allergic reactions to OMONTYS.
Warnings and Precautions
Increased mortality, myocardial infarction, stroke, and thromboembolism:
Using ESAs to target a hemoglobin level of greater than 11 g/dL
increases the risk of serious adverse cardiovascular reactions and has
not been shown to provide additional benefit. Use caution in patients
with coexistent cardiovascular disease and stroke. Patients with CKD
and an insufficient hemoglobin response to ESA therapy may be at even
greater risk for cardiovascular reactions and mortality. A rate of
hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
In controlled clinical trials of ESAs in patients with cancer,
increased risk for death and serious adverse cardiovascular reactions
including myocardial infarction and stroke was observed.
There is increased mortality and/or increased risk of tumor
progression or recurrence in patients with cancer receiving ESAs.
In controlled clinical trials of ESAs, ESAs increased the risk of
death in patients undergoing coronary artery bypass graft surgery
(CABG) and deep venous thrombosis (DVT) in patients undergoing
In 2 trials of OMONTYS, patients with CKD not on dialysis experienced
increased specific cardiovascular events.
Hypertension (see Contraindications): Appropriately control
hypertension prior to initiation of and during treatment with OMONTYS.
Reduce or withhold OMONTYS if blood pressure becomes difficult to
Serious allergic reactions (see Contraindications): Serious
allergic reactions have been reported with OMONTYS. Immediately and
permanently discontinue OMONTYS and administer appropriate therapy if a
serious allergic reaction occurs.
Lack or loss of response to OMONTYS: Initiate a search for
causative factors. If typical causes of lack or loss of hemoglobin
response are excluded, evaluate for antibodies to peginesatide.
Dialysis management: Patients receiving OMONTYS may require
adjustments to dialysis prescriptions and/or increased anticoagulation
with heparin to prevent clotting of the extracorporeal circuit during
Laboratory monitoring: Evaluate transferrin saturation and serum
ferritin prior to and during OMONTYS treatment. Administer supplemental
iron therapy when serum ferritin is less than 100mcg/L or when serum
transferrin saturation is less than 20%. Monitor hemoglobin every 2
weeks until stable and the need for RBC transfusions is minimized. Then,
Most common adverse reactions in clinical studies in patients with CKD
on dialysis treated with OMONTYS were dyspnea, diarrhea, nausea, cough,
and arteriovenous fistula site complication.
Please click here
for Full Prescribing Information, including Boxed WARNINGS, also
available at www.omontys.com.
OMONTYS Indication and Limitations of Use
OMONTYS® (peginesatide) Injection is indicated for the treatment of
anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
OMONTYS is not indicated and is not recommended for use in patients with
CKD not on dialysis, in patients receiving treatment for cancer and
whose anemia is not due to CKD, or as a substitute for red blood cell
(RBC) transfusions in patients who require immediate correction of
anemia. OMONTYS has not been shown to improve symptoms, physical
functioning, or health-related quality of life.
About Affymax, Inc.
Affymax, Inc. is a biopharmaceutical company based in Palo Alto,
California. Affymax's mission is to discover, develop and deliver
innovative therapies that improve the lives of patients with kidney
disease and other serious and often life-threatening illnesses.
The company's first marketed product, OMONTYS, was approved by the U.S.
Food and Drug Administration (FDA) in March 2012. For additional
information on Affymax, please visit www.affymax.com.
Affymax Forward-Looking Statement
This release contains forward-looking statements, including statements
regarding the importance of the EMERALD results, the potential
advantages of OMONTYS, the continuation and success
of Affymax's collaboration with Takeda and the commercialization of
OMONTYS. Affymax's actual results may differ materially from those
indicated in these forward-looking statements due to risks and
uncertainties, including risks relating to the factors affecting the
commercial potential of OMONTYS, the continued safety and efficacy of
OMONTYS, industry and competitive environment, regulatory requirements
by the FDA or other regulatory authorities, including post-marketing
studies, trials and Risk Evaluation and Mitigation Strategy, the
potential for disruptions to supply, financing requirements and our
ability to access capital and other matters that are described in
Affymax's Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission. Investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of
this release. Affymax undertakes no obligation to update any
forward-looking statement in this press release.
About Takeda Pharmaceuticals U.S.A., Inc. and Takeda Global Research
& Development Center, Inc.
Based in Deerfield, Ill., Takeda Pharmaceuticals U.S.A., Inc. and Takeda
Global Research & Development Center, Inc. are subsidiaries of Takeda
Pharmaceutical Company Limited, the largest pharmaceutical company in
Japan. The respective companies currently market oral diabetes,
insomnia, rheumatology, gastroenterology and cardiovascular disease
treatments and seek to bring innovative products to patients through a
pipeline that includes compounds in development for diabetes,
gastroenterology, neurology and other conditions. To learn more about
these Takeda companies, visit www.takeda.us.
Takeda Forward-Looking Statement
This press release contains forward-looking statements. Forward-looking
statements include statements regarding Takeda's plans, outlook,
strategies, results for the future, and other statements that are not
descriptions of historical facts. Forward-looking statements may be
identified by the use of forward-looking words such as "may," "believe,"
"will," "expect," "project," "estimate," "should," "anticipate," "plan,"
"assume," "continue," "seek," "pro forma," "potential," "target,"
"forecast," "guidance," "outlook" or "intend" or other similar words or
expressions of the negative thereof. Forward-looking statements are
based on estimates and assumptions made by management that are believed
to be reasonable, though they are inherently uncertain and difficult to
predict. Investors are cautioned not to unduly rely on such
Forward-looking statements involve risks and uncertainties that could
cause actual results or experience to differ materially from that
expressed or implied by the forward-looking statements. Some of these
risks and uncertainties include, but are not limited to, (1) the
economic circumstances surrounding Takeda's business, including general
economic conditions in Japan, the United States and worldwide; (2)
competitive pressures and developments; (3) applicable laws and
regulations; (4) the success or failure of product development programs;
(5) actions of regulatory authorities and the timing thereof; (6)
changes in exchange rates; (7) claims or concerns regarding the safety
or efficacy of marketed products or product candidates in development;
and (8) integration activities with acquired companies.
The forward-looking statements contained in this press release speak
only as of the date of this press release, and Takeda undertakes no
obligation to revise or update any forward-looking statements to reflect
new information, future events or circumstances after the date of the
forward-looking statement. If Takeda does update or correct one or more
of these statements, investors and others should not conclude that
Takeda will make additional updates or corrections.
Sylvia Wheeler, 650-812-8861
Pharmaceuticals U.S.A., Inc.
Jocelyn M. Gerst, 224-554-5542
Source: Affymax, Inc. and Takeda Pharmaceuticals U.S.A., Inc.
News Provided by Acquire Media
Close window | Back to top