Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s
leading producers of plasma-derived medicines, today announced that
the United States Food and Drug Administration (FDA) has approved
an expanded label for XEMBIFY®, the company’s 20% subcutaneous
immunoglobulin (SCIg), to include treatment-naïve patients with
primary humoral immunodeficiencies (PI).
XEMBIFY becomes the first 20% SCIg with this extended label,
allowing patients to begin SCIg therapy without first having
intravenous administration.
FDA approval of the Supplemental Biologics Application (sBLA)
also includes biweekly dosing and is supported by phase 4 clinical
trial (NCT04566692) data shared last year. XEMBIFY met its primary
endpoint, demonstrating that patients with PI treated with XEMBIFY
every two weeks achieved non-inferiority in total Ig levels
compared with those who received the medication every seven
days.
There were no unique safety issues identified in the trial and
the tolerability profiles were consistent between biweekly and
weekly administration. The phase 4 trial was a multicenter,
single-sequence, open-label study that included 27 subjects across
18 U.S. sites.
Greater adoption of XEMBIFY forms part of Grifols’ wider Ig
business strategy. The global market for Ig is expected to grow in
the high single digits in the coming years as a result of the
increase in PI and secondary immunodeficiencies (SID), which
together account for up to 55% of the total Ig market.1 Ig
treatment for immunodeficiencies is expected to outpace all other
indications.
“The XEMBIFY label expansion eliminates the need for patients to
have initial intravenous treatment, which differentiates XEMBIFY
from other SCIg therapies, plus offers patients greater convenience
and flexibility with biweekly dosing,” said Joerg Schuettrumpf,
Grifols Chief Scientific Innovation Officer. “Grifols plans to
launch the new label in the U.S. in the third quarter of 2024 as
part of the company’s commitment to increasing options for patients
and adapting to their needs and lifestyles.”
The biweekly dosing option is already available in the European
markets where XEMBIFY is commercialized, including Czech Republic,
France, Iceland, Norway, Slovakia, Spain and Sweden. The company is
also working on launching XEMBIFY in other European countries.
XEMBIFY is indicated for PI in the U.S. and both PI and select
SID in Europe, Canada and Australia.
About XEMBIFY®
Grifols XEMBIFY® is a 20% solution of purified human
immunoglobulin (primarily immune globulin G [IgG]) made from large
pools of human plasma via modifications of the Immune Globulin
(Human), 10% Caprylate/Chromatography Purified (IGIV-C 10%)
manufacturing process.
INDICATION
XEMBIFY® (immune globulin subcutaneous, human–klhw) is a 20%
immune globulin solution for subcutaneous injection indicated for
treatment of primary humoral immunodeficiency (PI) in patients 2
years of age and older. XEMBIFY® is for subcutaneous administration
only.IMPORTANT SAFETY INFORMATION
WARNING: THROMBOSIS
- Thrombosis
may occur with immune globulin products, including
XEMBIFY®. Risk factors
may include: advanced age, prolonged immobilization, estrogens,
indwelling vascular catheters, hyperviscosity, and cardiovascular
risk factors. Thrombosis may occur in the absence of known risk
factors
- For patients
at risk of thrombosis, administer
XEMBIFY® at the minimum
dose and infusion rate practicable. Ensure adequate hydration in
patients before administration. Monitor for signs and symptoms of
thrombosis and assess blood viscosity in patients at risk of
hyperviscosity
Contraindications
XEMBIFY® is contraindicated in patients who have had an
anaphylactic or severe systemic reaction to the administration of
human immune globulin. It is contraindicated in IgA-deficient
patients with antibodies against IgA and a history of
hypersensitivity.
Warnings and Precautions
Aseptic meningitis syndrome (AMS). AMS may
occur with human immune globulin treatment, including XEMBIFY®.
Conduct a thorough neurological exam on patients exhibiting signs
and symptoms to rule out other causes of meningitis.
Discontinuation of treatment has resulted in remission within
several days without sequelae.
Thrombosis. Thrombosis may occur following
treatment with immune globulin products, including XEMBIFY®.
Thrombosis may occur in the absence of known risk factors. In
patients at risk, administer at the minimum dose and infusion rate
practicable. Ensure adequate hydration before administration.
Monitor for signs and symptoms of thrombosis and assess blood
viscosity in patients at risk of hyperviscosity.
Hypersensitivity. Severe hypersensitivity
reactions may occur with immune globulin products, including
XEMBIFY®. In case of hypersensitivity, discontinue infusion
immediately and institute appropriate treatment. XEMBIFY contains
IgA. Patients with known antibodies to IgA may have a greater risk
of developing potentially severe hypersensitivity and anaphylactic
reactions.
Renal dysfunction/failure. Acute renal
dysfunction/failure, acute tubular necrosis, proximal tubular
nephropathy, osmotic nephrosis, and death may occur with use of
human immune globulin products, especially those containing
sucrose. XEMBIFY® does not contain sucrose. Ensure patients are not
volume-depleted prior to starting infusion. In patients at risk due
to preexisting renal insufficiency or predisposition to acute renal
failure, assess renal function prior to the initial infusion of
XEMBIFY® and again at appropriate intervals thereafter. If renal
function deteriorates, consider discontinuation.
Hemolysis. XEMBIFY® may contain blood group
antibodies that may cause a positive direct antiglobulin reaction
and hemolysis. Monitor patients for clinical signs and symptoms of
hemolysis. If signs and symptoms are present after infusion,
perform confirmatory lab testing.
Transfusion-related acute lung injury (TRALI).
Noncardiogenic pulmonary edema may occur in patients following
treatment with immune globulin products, including XEMBIFY®.
Monitor patients for pulmonary adverse reactions. If TRALI is
suspected, perform appropriate tests for the presence of
antineutrophil and anti-HLA antibodies in both the product and
patient serum. TRALI may be managed using oxygen therapy with
adequate ventilatory support.
Transmissible infectious agents. Because
XEMBIFY® is made from human blood, it may carry a risk of
transmitting infectious agents, eg, viruses, the variant
Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the
Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of
viral diseases, vCJD, or CJD have ever been associated with the use
of XEMBIFY®.
Interference with lab tests. After infusion of
XEMBIFY®, passively transferred antibodies in the patient’s blood
may yield positive serological testing results, with the potential
for misleading interpretation.
Adverse Reactions
The most common adverse reactions in ≥ 5% of subjects in the
clinical trial were local adverse reactions, including
infusion-site erythema (redness), infusion-site pain, infusion-site
swelling (puffiness), infusion-site bruising, infusion-site nodule,
infusion-site pruritus (itching), infusion-site induration
(firmness), infusion-site scab, infusion-site edema, and systemic
reactions including cough and diarrhea.
Drug InteractionsPassive transfer of antibodies
may transiently interfere with the immune responses to live
attenuated virus vaccines (eg, measles, mumps, rubella, and
varicella).
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Please see full Prescribing Information for XEMBIFY® or visit
www.xembify.com
Globally, prescribing information varies; refer to the
individual country product label for complete information.
About Grifols
Grifols is a global healthcare company founded in Barcelona in
1909 committed to improving the health and well-being of people
around the world. A leader in essential plasma-derived medicines
and transfusion medicine, the company develops, produces and
provides innovative healthcare services and solutions in more than
110 countries.
Patient needs and Grifols’ ever-growing knowledge of many
chronic, rare and prevalent conditions, at times life-threatening,
drive the company’s innovation in both plasma and other
biopharmaceuticals. The company is focused on treating conditions
across a broad range of therapeutic areas: immunology, hepatology
and intensive care, pulmonology, hematology, neurology and
infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its
network of donation centers, the world’s largest with over 390
across North America, Europe, Africa and the Middle East and
China.
As a recognized leader in transfusion medicine, Grifols offers a
comprehensive portfolio of solutions designed to enhance safety
from donation to transfusion, in addition to clinical diagnostic
technologies. It provides high-quality biological supplies for
life-science research, clinical trials, and for manufacturing
pharmaceutical and diagnostic products. The company also supplies
tools, information and services that enable hospitals, pharmacies
and healthcare professionals to efficiently deliver expert medical
care.
Grifols, with more than 24,000 employees in more
than 30 countries and regions, is committed to a sustainable
business model that sets the standard for continuous innovation,
quality, safety and ethical leadership.
The company’s class A shares are listed on the Spanish Stock
Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols
non-voting class B shares are listed on the Mercado Continuo
(MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information, please visit
www.grifols.com
MEDIA CONTACT:
Media Press Officemedia@grifols.comTel. +34 93
571 00 02
INVESTORS: Investors Relations
Department & Sustainabilityinversores@grifols.com -
investors@grifols.com Tel. +34 93 571 02 21
LEGAL DISCLAIMER
The facts and figures contained in this report
that do not refer to historical data are “future projections and
assumptions”. Words and expressions such as “believe”, “hope”,
“anticipate”, “predict”, “expect”, “intend”, “should”, “will seek
to achieve”, “it is estimated”, “future” and similar expressions,
insofar as they relate to the Grifols group, are used to identify
future projections and assumptions. These expressions reflect the
assumptions, hypotheses, expectations and predictions of the
management team at the time of writing this report, and these are
subject to a number of factors that mean that the actual results
may be materially different. The future results of the Grifols
group could be affected by events relating to its own activities,
such as a shortage of supplies of raw materials for the manufacture
of its products, the appearance of competitor products on the
market, or changes to the regulatory framework of the markets in
which it operates, among others. At the date of compiling this
report, the Grifols group has adopted the necessary measures to
mitigate the potential impact of these events. Grifols, S.A. does
not accept any obligation to publicly report, revise or update
future projections or assumptions to adapt them to events or
circumstances subsequent to the date of writing this report, except
where expressly required by the applicable legislation. This
document does not constitute an offer or invitation to buy or
subscribe shares in accordance with the provisions of the following
Spanish legislation: Royal Legislative Decree 4/2015, of 23
October, approving recast text of Securities Market Law; Royal
Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4
November, and any regulations developing this legislation. In
addition, this document does not constitute an offer of purchase,
sale or exchange, or a request for an offer of purchase, sale or
exchange of securities, or a request for any vote or approval in
any other jurisdiction. The information included in this document
has not been verified nor reviewed by the external auditors of the
Grifols group.
© 2024 Grifols
All Rights Reserved
July
2024 US-XEM-2400176
1 Marketing Research Bureau. Global Usage and Forecast of the
Immunoglobulin Market by Region
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