Recorlev® (levoketoconazole) now exclusively
available through PANTHERx Rare Specialty Pharmacy
To increase patient access to Recorlev, the
Company has established Xeris CareConnection™, a comprehensive
support program, which includes $0 co-pay for commercially insured
patients, one-on-one support and education for patients, and
reimbursement and access support.
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a
biopharmaceutical company developing and commercializing unique
therapies for patient populations in endocrinology, neurology, and
gastroenterology, today announced that Recorlev® (levoketoconazole)
is now available for prescription. The U.S. Food and Drug
Administration (FDA) approved Recorlev on December 31, 2021 for the
treatment of endogenous hypercortisolemia in adult patients with
Cushing’s syndrome for whom surgery is not an option or has not
been curative.1
“The commercial availability of Recorlev represents a
significant milestone for the Cushing’s syndrome community,
particularly for people living with uncontrolled disease, who until
now were faced with limited therapeutic options,” said Paul R.
Edick, Chairman and CEO of Xeris Biopharma. “Xeris is proud to
introduce this meaningful new treatment option to patients in the
U.S. and is focused on meeting the needs of the rare disease
community by ensuring access to treatment and providing
comprehensive patient and physician support services.”
Xeris has also partnered with PANTHERx Rare Specialty Pharmacy
to provide a customized support and product distribution program,
Xeris CareConnection™, for members of the Recorlev ecosystem,
including patients, caregivers, physicians, and payors. Xeris
CareConnection provides access to pharmacists, case managers and
access managers, including white-glove services throughout the
entire treatment journey. Patients will also receive welcome
information, therapy onboarding, at-home delivery of medication, a
discreet courier service for urinary free cortisol (UFC) test
collection, automatic monthly refill shipments, financial
assistance, one-on-one support, and ongoing educational resources.
Xeris CareConnection also supports healthcare professionals and
their teams through education on access and reimbursement. To get
started with Recorlev, reach out to Xeris CareConnection (available
Monday–Friday, 8 a.m.–7 p.m. ET) at 1-844-444-RCLV (7258).
“Endogenous Cushing’s syndrome (CS), a rare and potentially
fatal endocrine disease caused by chronic, elevated cortisol
exposure, affects women three times more often than men,” said Ken
Johnson, Pharm.D., SVP, Global Development and Medical Affairs at
Xeris. “Normalization of cortisol levels is the first and most
important clinical objective in the treatment of Cushing’s syndrome
and the approval of new medicines like Recorlev can aid physicians
and patients to achieve this objective. Many of the symptoms of CS
can significantly impact self-esteem, body image, and intimate
relationships, therefore, it is exciting to now be able to offer
patients suffering from this condition an effective oral treatment
option.”
Xeris is committed to ensuring that everyone who needs access to
their therapies will receive it. Consequently, Xeris has
established a $0 co-pay program and Patient Assistance Program for
eligible patients with financial hardship or limited or no
insurance. For more information, please visit www.RECORLEV.com.
The FDA approval of Recorlev® was based upon safety and efficacy
data from two positive Phase 3 studies that evaluated a combined
study population of 166 patients, which was representative of the
adult drug-treated U.S. population with Cushing’s syndrome.1
LOGICS, a double-blind, placebo-controlled randomized-withdrawal
study met its key endpoint of normalizing and maintaining
therapeutic response compared with placebo (detailed results
here).1 The supportive SONICS study met its primary and key
secondary endpoints, significantly reducing and normalizing mean
urinary free cortisol concentrations without a dose increase
(detailed results here).1,2
About Cushing’s Syndrome Endogenous Cushing’s syndrome is
a rare, serious, and potentially fatal endocrine disease caused by
chronic elevated cortisol exposure—often the result of a benign
tumor of the pituitary gland. This benign tumor tells the body to
overproduce high levels of cortisol for a sustained period of time,
which often results in characteristic physical signs and symptoms
that are distressing to patients. The disease is most common among
adults between the ages of 30–50, and it affects women three times
more often than men. Women with Cushing's syndrome may experience a
variety of health issues including menstrual problems, difficulty
becoming pregnant, excess male hormones (androgens), primarily
testosterone, which can cause hirsutism (growth of coarse body hair
in a male pattern), oily skin, and acne.3
Additionally, the multisystem complications of the disease are
potentially life threatening. These include metabolic changes such
as high blood sugar or diabetes, high blood pressure, high
cholesterol, fragility of various tissues including blood vessels,
skin, muscle, and bone, and psychological disturbances such as
depression, anxiety, and insomnia.3 Untreated, the five-year
survival rate is only approximately 50%.4
About Recorlev Recorlev® (levoketoconazole) is a cortisol
synthesis inhibitor for the treatment of endogenous
hypercortisolemia in adult patients with Cushing’s syndrome for
whom surgery is not an option or has not been curative.1 Endogenous
Cushing’s syndrome is a rare but serious and potentially fatal
endocrine disease caused by chronic elevated cortisol exposure.2
Recorlev is the pure 2S,4R enantiomer of ketoconazole, a
steroidogenesis inhibitor.1 Recorlev has demonstrated in two
successful Phase 3 studies to significantly reduce mean urinary
free cortisol.1
The Phase 3 program for Recorlev included LOGICS and SONICS, two
multinational studies designed to evaluate the safety and efficacy
of Recorlev when used to treat endogenous Cushing’s syndrome.
LOGICS, a double-blind, placebo-controlled randomized-withdrawal
study met its key endpoint of normalizing and maintaining
therapeutic response compared with placebo (detailed results
here).1 The supportive SONICS study met its primary and
secondary endpoints, significantly reducing and normalizing mean
urinary free cortisol concentrations without a dose increase.1,2
The ongoing open-label OPTICS study will gather further useful
information related to the long-term use of Recorlev.
Recorlev received orphan drug designation from the FDA and the
European Medicines Agency for the treatment of endogenous Cushing's
syndrome.
Indication & Important Safety Information for Recorlev®
BOXED WARNING: HEPATOTOXICITY AND QT PROLONGATION HEPATOTOXICITY
Cases of hepatotoxicity with fatal outcome or requiring liver
transplantation have been reported with oral ketoconazole. Some
patients had no obvious risk factors for liver disease. Recorlev is
associated with serious hepatotoxicity. Evaluate liver enzymes
prior to and during treatment.
QT PROLONGATION Recorlev is associated with dose-related QT
interval prolongation. QT interval prolongation may result in
life-threatening ventricular dysrhythmias such as torsades de
pointes. Perform ECG and correct hypokalemia and hypomagnesemia
prior to and during treatment.
INDICATION Recorlev is a cortisol synthesis inhibitor
indicated for the treatment of endogenous hypercortisolemia in
adult patients with Cushing’s syndrome for whom surgery is not an
option or has not been curative. Limitations
of Use Recorlev is not approved for the treatment of fungal
infections.
CONTRAINDICATIONS
- Cirrhosis, acute liver disease or poorly controlled chronic
liver disease, baseline AST or ALT > 3 times the upper limit of
normal, recurrent symptomatic cholelithiasis, a prior history of
drug induced liver injury due to ketoconazole or any azole
antifungal therapy that required discontinuation of treatment, or
extensive metastatic liver disease.
- Taking drugs that cause QT prolongation associated with
ventricular arrhythmias, including torsades de pointes.
- Prolonged QTcF interval > 470 msec at baseline, history of
torsades de pointes, ventricular tachycardia, ventricular
fibrillation, or prolonged QT syndrome.
- Known hypersensitivity to levoketoconazole, ketoconazole or any
excipient in Recorlev.
- Taking certain drugs that are sensitive substrates of CYP3A4 or
CYP3A4 and P-gp.
WARNINGS AND PRECAUTIONS Hepatotoxicity Serious hepatotoxicity has been
reported in patients receiving Recorlev, irrespective of the
dosages used or the treatment duration. Drug-induced liver injury
(peak ALT or AST greater than 3 times upper limit of normal)
occurred in patients using Recorlev. Avoid concomitant use of
Recorlev with hepatotoxic drugs. Advise patient to avoid excessive
alcohol consumption while on treatment with Recorlev. Routinely
monitor liver enzymes and bilirubin during treatment. QT Prolongation Use Recorlev with caution in
patients with other risk factors for QT prolongation, such as
congestive heart failure, bradyarrhythmias, and uncorrected
electrolyte abnormalities, with more frequent ECG monitoring
considered. Routinely monitor ECG and blood potassium and magnesium
levels during treatment. Hypocortisolism Recorlev lowers cortisol levels
and may lead to hypocortisolism with a potential for
life-threatening adrenal insufficiency. Lowering of cortisol levels
can cause nausea, vomiting, fatigue, abdominal pain, loss of
appetite, and dizziness. Significant lowering of serum cortisol
levels may result in adrenal insufficiency that can be manifested
by hypotension, abnormal electrolyte levels, and hypoglycemia.
Routinely monitor 24-hour urine free cortisol, morning serum or
plasma cortisol, and patient’s signs and symptoms for
hypocortisolism during treatment. Hypersensitivity Reactions Hypersensitivity to
Recorlev has been reported. Anaphylaxis and other hypersensitivity
reactions including urticaria have been reported with oral
ketoconazole. Risks Related to Decreased
Testosterone Recorlev may lower serum testosterone in men
and women. Potential clinical manifestations of decreased
testosterone concentrations in men may include gynecomastia,
impotence, and oligospermia. Potential clinical manifestations of
decreased testosterone concentrations in women include decreased
libido and mood changes.
ADVERSE REACTIONS Most common adverse reactions
(incidence > 20%) are nausea/vomiting, hypokalemia,
hemorrhage/contusion, systemic hypertension, headache, hepatic
injury, abnormal uterine bleeding, erythema, fatigue, abdominal
pain/dyspepsia, arthritis, upper respiratory infection, myalgia,
arrhythmia, back pain, insomnia/sleep disturbances, and peripheral
edema.
DRUG INTERACTIONS
- Consult approved product labeling for drugs that are substrates
of CYP3A4, P-gp, OCT2, and MATE prior to initiating Recorlev.
- Sensitive CYP3A4 or CYP3A4 and P-gp
Substrates: Concomitant use of Recorlev with these
substrates is contraindicated or not recommended.
- Atorvastatin: Use lowest
atorvastatin dose possible and monitor for adverse reactions for
dosages exceeding 20 mg daily.
- Metformin: Monitor glycemia,
kidney function, and vitamin B12 and adjust metformin dosage as
needed.
- Strong CYP3A4 Inhibitors or
Inducers: Avoid use of these drugs 2 weeks before and during
Recorlev treatment.
- Gastric Acid Modulators: See Full
Prescribing Information for recommendations regarding concomitant
use with Recorlev.
USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed during
treatment and for one day after final dose.
To report SUSPECTED ADVERSE REACTIONS, contact Xeris
Pharmaceuticals, Inc. at 1-877-937-4737 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Please see Full Prescribing
Information, including Boxed Warning.
About Xeris Biopharma Xeris (Nasdaq: XERS) is a
biopharmaceutical company developing and commercializing unique
therapies for patient populations in endocrinology, neurology, and
gastroenterology. Xeris has three commercially available products;
Gvoke®, a ready-to-use liquid glucagon for the treatment of severe
hypoglycemia, Keveyis®, the first and only FDA-approved therapy for
primary periodic paralysis, and Recorlev® for the treatment of
endogenous Cushing’s syndrome. Xeris also has a robust pipeline of
development programs to extend the current marketed products into
important new indications and uses and bring new products forward
using its proprietary formulation technology platforms, XeriSol™
and XeriJect™, supporting 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 statements regarding the market
and therapeutic potential of its products and product candidates,
expectations regarding the timing of the commercial launch of
Recorlev, estimates and projections about the potential benefits of
the Strongbridge Biopharma acquisition, the future performance of
the combined company and estimated synergies, the timing or
likelihood of expansion into additional markets and other
statements containing the words “will,” “would,” “continue,” and
similar expressions, constitute forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, reliance on
third-party suppliers for Gvoke®, Ogluo®, Keveyis®, and Recorlev®
the regulatory approval of its product candidates, its ability to
market and sell its products, failure to realize the expected
benefits of the acquisition, failure to promptly and effectively
integrate Strongbridge’s businesses, general economic and business
conditions that affect the combined company following the
consummation of the acquisition, the impact of the COVID-19
pandemic on the combined company following the consummation of the
transaction, changes in global, political, economic, business,
competitive, market and regulatory forces, future exchange and
interest rates, changes in tax laws, regulations, rates and
policies, future business acquisitions or disposals and competitive
developments and the other risks described in our Quarterly Report
on Form 10-Q and other reports we file from time to time with the
SEC. 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, 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 factors described in the context of such
forward-looking statements in this communication could cause Xeris’
plans with respect to Strongbridge, Xeris’ plans with respect to
its products and product candidates, Xeris’ actual results,
performance or achievements, industry results and developments to
differ materially from those expressed in or implied by such
forward-looking statements. Although it is believed that the
expectations reflected in such forward-looking statements are
reasonable, no assurance can be given that such expectations will
prove to have been correct and persons reading this communication
are therefore cautioned not to place undue reliance on these
forward-looking statements which speak only as at the date of this
communication. Additional information about economic, competitive,
governmental, technological, and other factors that may affect
Xeris is set forth in Item 1A, “Risk Factors,” in Xeris’ 2020
Annual Report on Form 10-K, which has been filed with the SEC and
other important factors in Xeris’ subsequent filings with the SEC,
the contents of which are not incorporated by reference into, nor
do they form part of, this communication. Additional information
about economic, competitive, governmental, technological, and other
factors that may affect Strongbridge is set forth in Item 1A, “Risk
Factors,” in Strongbridge’s 2020 Annual Report on Form 10-K, which
has been filed with the SEC, the contents of which are not
incorporated by reference into, nor do they form part of, this
communication. Any forward-looking statements in this communication
are based upon information available to Xeris, as of the date of
this communication and, while believed to be true when made, may
ultimately prove to be incorrect. Subject to any obligations under
applicable law, Xeris does 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. All subsequent written and oral
forward-looking statements attributable to Xeris or any person
acting on behalf of any of them are expressly qualified in their
entirety by this paragraph.
1. Recorlev [prescribing information]. Chicago, IL: Xeris
Pharmaceuticals, Inc.; 2021. 2. Fleseriu M, et al. Lancet Diabetes
Endocrinol. 2019;7(11):855-865. 3. Pivonello R et al. Lancet
Diabetes Endocrinol. 2016; 4: 611-29. 4. Plotz CM, et al. Am J Med.
1952 November;13(5):597-614.
Recorlev®, Xeris Pharmaceuticals®, Xeris CareConnectionTM,
Keveyis®, Gvoke®, and Ogluo® are trademarks owned by or licensed to
Xeris Pharmaceuticals, Inc. PANTHERx Rare Pharmacy is a service
mark of PANTHERx Rare, LLC. All other trademarks referenced herein
are the property of their respective owners. All rights reserved.
US-PR-22-00001 1/22
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version on businesswire.com: https://www.businesswire.com/news/home/20220131005297/en/
Investor Contact: Allison Wey Senior Vice President,
Investor Relations and Corporate Communications
awey@xerispharma.com (312) 736-1237
Media Contact: Lindsay Rocco Elixir Health PR
lrocco@elixirhealthpr.com (862) 596-1304
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