Updated guidelines recognize the benefits of
ready-to-use glucagon
Protecting all people with diabetes at risk of
severe hypoglycemia remains the goal
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented
biopharmaceutical company committed to improving patients’ lives by
developing and commercializing innovative products across a range
of therapies, today announced that Xeris has shipped more than one
million units of Gvoke® – the company’s ready-to-use liquid
glucagon for the treatment of severe hypoglycemia in adults and
children with diabetes ages 2 years and above.
“We are proud to celebrate this major milestone of having
shipped over one million units of Gvoke since its launch,” said
Paul R. Edick, Xeris’ Chairman and CEO. “However, far too many
people with diabetes are still left without protection against a
potentially life-threatening severe low blood sugar event. Based on
recently updated guidelines by the American Diabetes Association1
and others, we estimate that approximately 15 million people2 with
diabetes are at increased risk of low blood sugar, a primary risk
factor being on insulin, and should be carrying a ready-to-use
glucagon, like Gvoke HypoPen®,” Mr. Edick continued, “We will
continue to work tirelessly towards our mission of protecting as
many of the 15 million as possible and call on the medical
community to take responsibility to make these new standards of
care your standards of practice.”
About Gvoke®
Gvoke® PFS and Gvoke HypoPen® (glucagon injection), the first
prescription, ready-to-use, pre-mixed, pre-measured glucagon
injection, were approved by the FDA in September 2019 for use in
the United States. Gvoke is indicated for the treatment of severe
hypoglycemia in pediatric and adult patients with diabetes ages 2
years and above. In August 2021, the FDA approved Gvoke® Kit, the
first ready-to-use glucagon available in a single-use vial and
single-use syringe kit for rescue.
INDICATION AND IMPORTANT SAFETY INFORMATION
GVOKE is indicated for the treatment of severe hypoglycemia in
adult and pediatric patients with diabetes ages 2 years and
above.
IMPORTANT SAFETY INFORMATION
Contraindications
GVOKE is contraindicated in patients with pheochromocytoma
because of the risk of substantial increase in blood pressure,
insulinoma because of the risk of hypoglycemia, and known
hypersensitivity to glucagon or to any of the excipients in GVOKE.
Allergic reactions have been reported with glucagon and include
anaphylactic shock with breathing difficulties and hypotension.
Warnings and Precautions
GVOKE is contraindicated in patients with pheochromocytoma
because glucagon may stimulate the release of catecholamines from
the tumor. If the patient develops a dramatic increase in blood
pressure and a previously undiagnosed pheochromocytoma is
suspected, 5 to 10 mg of phentolamine mesylate, administered
intravenously, has been shown to be effective in lowering blood
pressure.
In patients with insulinoma, administration of glucagon may
produce an initial increase in blood glucose; however, GVOKE
administration may directly or indirectly (through an initial rise
in blood glucose) stimulate exaggerated insulin release from an
insulinoma and cause hypoglycemia. GVOKE is contraindicated in
patients with insulinoma. If a patient develops symptoms of
hypoglycemia after a dose of GVOKE, give glucose orally or
intravenously.
Allergic reactions have been reported with glucagon. These
include generalized rash, and in some cases, anaphylactic shock
with breathing difficulties and hypotension. GVOKE is
contraindicated in patients with a prior hypersensitivity
reaction.
GVOKE is effective in treating hypoglycemia only if sufficient
hepatic glycogen is present. Patients in states of starvation, with
adrenal insufficiency or chronic hypoglycemia, may not have
adequate levels of hepatic glycogen for GVOKE administration to be
effective. Patients with these conditions should be treated with
glucose.
Necrolytic migratory erythema (NME), a skin rash commonly
associated with glucagonomas (glucagon producing tumors) and
characterized by scaly, pruritic erythematous plaques, bullae, and
erosions, has been reported postmarketing following continuous
glucagon infusion. NME lesions may affect the face, groin, perineum
and legs or be more widespread. In the reported cases NME resolved
with discontinuation of the glucagon, and treatment with
corticosteroids was not effective. Should NME occur, consider
whether the benefits of continuous glucagon infusion outweigh the
risks.
Adverse Reactions
Most common (≥5%) adverse reactions associated with GVOKE are
nausea, vomiting, injection site edema (raised 1 mm or greater),
and hypoglycemia.
Drug Interactions
Patients taking beta-blockers may have a transient increase in
pulse and blood pressure when given GVOKE. In patients taking
indomethacin, GVOKE may lose its ability to raise blood glucose or
may even produce hypoglycemia. GVOKE may increase the anticoagulant
effect of warfarin.
Please see full Prescribing Information for GVOKE on
www.xerispharma.com. Manufactured for Xeris Pharmaceuticals, Inc.
by Pyramid Laboratories Inc., Costa Mesa, CA 92626.
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical
company committed to improving patients’ lives by developing and
commercializing differentiated and innovative products across a
range of therapies. Xeris has three commercially available
products: Gvoke®, a ready-to-use liquid glucagon for the treatment
of severe hypoglycemia; Keveyis®, a proven therapy for primary
periodic paralysis; and Recorlev® for the treatment of endogenous
Cushing’s syndrome. Xeris has a diverse pipeline of development and
partnered programs using its formulation sciences, XeriSol™ and
XeriJect™, to support long-term product development and commercial
success.
Xeris Biopharma Holdings is headquartered in Chicago, IL. For
more information, visit www.xerispharma.com, or follow us on
Twitter, LinkedIn, or Instagram.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Xeris Biopharma Holdings, Inc., including
the market and therapeutic potential of Gvoke®, the potential
utility of its formulation platforms and other statements
containing the words “will,” “would,” “continue,” “expect,”
“anticipate,” “estimate” and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on numerous assumptions and assessments made
in light of Xeris’ experience and perception of historical trends,
current conditions, business strategies, operating environment,
future developments, geopolitical factors and other factors it
believes appropriate. By their nature, forward-looking statements
involve known and unknown risks and uncertainties because they
relate to events and depend on circumstances that will occur in the
future. The various factors that could cause Xeris’ actual results,
performance or achievements, industry results and developments to
differ materially from those expressed in or implied by such
forward-looking statements, include its financial position and need
for financing, including to fund its product development programs
or commercialization efforts, whether its products will achieve and
maintain market acceptance in a competitive business environment,
its reliance on third-party suppliers, including single-source
suppliers, its reliance on third parties to conduct clinical
trials, the ability of its product candidates to compete
successfully with existing and new drugs, and its and
collaborators’ ability to protect its intellectual property and
proprietary technology. No assurance can be given that such
expectations will be realized and persons reading this
communication are, therefore, cautioned not to place undue reliance
on these forward-looking statements. Additional information about
potential impacts of financial, operational, economic, competitive,
regulatory, governmental, technological, and other factors that may
affect Xeris can be found in Xeris’ filings, including its most
recently filed Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission, the contents of which are not
incorporated by reference into, nor do they form part of, this
communication. Forward-looking statements in this communication are
based on information available to us, as of the date of this
communication and, while believed to be reasonable, actual results
may differ materially. Subject to any obligations under applicable
law, we do not undertake any obligation to update any
forward-looking statement whether as a result of new information,
future developments or otherwise, or to conform any forward-looking
statement to actual results, future events, or to changes in
expectations.
1.
American Diabetes Association, Diabetes
Care, 2023;46(suppl 1):S97-S110
2.
Xeris internal estimate
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version on businesswire.com: https://www.businesswire.com/news/home/20230731452188/en/
Allison Wey Senior Vice President, Investor Relations and
Corporate Communications awey@xerispharma.com 312-736-1237
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