Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection
PALO ALTO, Calif. & OSAKA, Japan--(BUSINESS WIRE)--
Affymax, Inc. (Nasdaq: AFFY) and Takeda Pharmaceutical Company Limited
(Takeda) today have decided to voluntarily recall all lots of OMONTYS®
(peginesatide) Injection to the user level as a result of new
postmarketing reports regarding serious hypersensitivity reactions,
including anaphylaxis, which can be life-threatening or fatal. The
companies have been working actively with the U.S. Food and Drug
Administration (FDA) which has indicated its agreement with this
decision. The companies have also issued a letter to health care
professionals indicating that no new or existing patients should receive
To date, fatal reactions have been reported in approximately 0.02% of
patients following the first dose of intravenous administration. The
reported serious hypersensitivity reactions have occurred within 30
minutes after such administration of OMONTYS. There have been no reports
of such reactions following subsequent dosing, or in patients who have
completed their dialysis session. Since launch, more than 25,000
patients have received OMONTYS in the postmarketing setting. The rate of
overall hypersensitivity reactions reported is approximately 0.2% with
approximately a third of these being serious in nature including
anaphylaxis requiring prompt medical intervention and in some cases
hospitalization. The companies are actively investigating these cases.
In the meantime, dialysis organizations are instructed to discontinue
use. Customers will be provided instructions on how to return the
product to the manufacturer for a refund. For customers with questions,
please call 1-855-466-6689 [9:00 a.m. to 5:00 p.m. Eastern Standard
Time, Monday through Friday].
OMONTYS (peginesatide) Injection is indicated for the treatment of
anemia due to chronic kidney disease in adult patients on dialysis and
is packaged in 10 mg and 20 mg Multi-dose vials:
10mg Multi-dose Vials - NDC 64764-610-10
20mg Multi-dose vials - NDC 64764-620-20
All lots of OMONTYS are affected by this recall:
10 mg Multi-dose vials
20 mg Multi-dose vials
Lots C18685, C18881, C19258
Lots C18686, C18696
The product can be identified by its product labeling featuring the name
OMONTYS. OMONTYS was distributed Nationwide, including Puerto Rico and
Guam, to dialysis centers via specialty distributors.
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA's MedWatch Adverse Event Reporting
program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and
Affymax Teleconference and Webcast
Affymax will host a teleconference and webcast at 5:30 a.m. Pacific
Time; 8:30 a.m. Eastern Time on Monday, February 25 to further discuss
this news announcement. Interested parties can listen to the live
teleconference by dialing (866) 393-1565 from the U.S. or +1(973)
409-9608 for international callers. Individuals may access the live
audio webcast by visiting www.affymax.com
and going to the Investors section. A replay of the webcast will be
available on the company's website for 30 days following the live event.
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
OMONTYS is contraindicated in patients with uncontrolled hypertension
and in patients who have had serious allergic reactions, which may
include anaphylaxis, 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, including anaphylactic reactions, hypotension,
bronchospasm, angioedema and generalized pruritus, may occur in patients
treated 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. For
additional information on Affymax, please visit www.affymax.com.
Affymax Forward-Looking Statement
This release contains forward-looking statements, including statements
regarding the potential attributes and safety profile 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 recall and
adverse events, ability to re-introduce OMONTYS to the market and future
acceptance by dialysis organizations, patients and the medical
community, and other factors affecting the commercial potential of
OMONTYS, the continued safety and efficacy of OMONTYS, the industry and
competitive environment, regulatory requirements or actions by the FDA
or other regulatory authorities, including withdrawal, further changes
to the label, post-marketing studies, trials and Risk Evaluation and
Mitigation Strategy, the potential for disruptions to supply, potential
litigation, 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
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with
its main focus on pharmaceuticals. As the largest pharmaceutical company
in Japan and one of the global leaders of the industry, Takeda is
committed to strive towards better health for patients worldwide through
leading innovation in medicine. Additional information about Takeda is
available through its corporate website, www.takeda.com.
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.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20130223005032/en/
Sylvia Wheeler, 650-812-8861
Pharmaceuticals U.S.A., Inc
Jocelyn M. Gerst, 224-554-5542
Pharmaceutical Company Limited
Corporate Communications Dept.
Source: Affymax, Inc. & Takeda Pharmaceutical Company Limited
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