ZEPOSIA is the first and only approved
sphingosine-1-phosphate (S1P) receptor modulator with no
genetic test or first dose observation at
initiation*1,2,3
ZEPOSIA 360 Support™ Program offers support
to help appropriate MS patients access ZEPOSIA
Bristol Myers Squibb (NYSE: BMY) today announced that ZEPOSIA®
(ozanimod) 0.92 mg, a new once-daily oral medication for adults for
the treatment of relapsing forms of multiple sclerosis (RMS),
including clinically isolated syndrome, relapsing-remitting
disease, and active secondary progressive disease, is now
commercially available in the U.S. ZEPOSIA was approved by the U.S.
Food and Drug Administration (FDA) on March 25, 2020.1
*ZEPOSIA is the only approved sphingosine-1-phosphate (S1P)
receptor modulator that offers appropriate RMS patients an
initiation with no genetic test and no first dose observation.1,2,3
An up-titration scheme should be used to reach the maintenance
dosage of ZEPOSIA, as a transient decrease in heart rate and
atrioventricular conduction delays may occur.1 Before initiation of
treatment with ZEPOSIA, all patients require assessments including
a recent complete blood count including a lymphocyte count (within
six months or after discontinuation of prior MS therapy), an ECG to
determine whether preexisting conduction abnormalities are present,
a recent liver function test (within six months), and consideration
of current and prior medications, including vaccinations.1 For
patients with a history of uveitis or macular edema, an ophthalmic
assessment is required.1
“We are pleased to now bring ZEPOSIA, an important new once
daily treatment option, to RMS patients,” said Tina Deignan, vice
president and U.S. head of immunology, Bristol Myers Squibb.
“ZEPOSIA is the first and only S1P that requires no first dose
observation,1,2,3 which may minimize the number of interactions RMS
patients need to have with healthcare practioners prior to
initiating therapy during this unprecedented time of social
distancing.”
ZEPOSIA is contraindicated in patients who in the last six
months experienced myocardial infarction, unstable angina, stroke,
transient ischemic attack (TIA), decompensated heart failure
requiring hospitalization, or Class III/IV heart failure; patients
who have a presence of Mobitz type II second or third-degree
atrioventricular (AV) block, sick sinus syndrome, or sino-atrial,
unless the patient has a functioning pacemaker; patients with
severe untreated sleep apnea; and patients taking a monoamine
oxidase inhibitor.1 ZEPOSIA is associated with the following
Warnings and Precautions: increased risk of infections,
bradyarrhythmia and atrioventricular conduction delays, liver
injury, fetal risk, increased blood pressure, respiratory effects,
macular edema, posterior reversible encephalopathy syndrome,
additive immunosuppressive effects from prior immune-modulating
treatments, severe increase in disability after stopping ZEPOSIA,
and immune system effects after stopping ZEPOSIA.1 Please see
Important Safety Information for additional details.1 The most
common adverse reactions (incidence ≥4%) were upper respiratory
infection, hepatic transaminase elevation, orthostatic hypotension,
urinary tract infection, back pain, and hypertension.1
The ZEPOSIA 360 Support™ program will facilitate access to
ZEPOSIA for appropriate patients with MS. This includes a co-pay of
as little as $0 for eligible appropriate patients, assistance with
financial support, reimbursement for some initial out-of-pocket
medical costs – and a program that may help eligible patients with
commercial insurance to receive free medication while they are
waiting for insurance approvals. Terms, conditions, and eligibility
criteria apply. More information is available at ZEPOSIA.com.
About Multiple Sclerosis
Multiple sclerosis (MS) is a disease in which the immune system
attacks the protective myelin sheath that covers the nerves.4 The
myelin damage disrupts communication between the brain and the rest
of the body.5 Ultimately, the nerves themselves may deteriorate — a
process that's currently irreversible.6
RMS, including clinically isolated syndrome, relapsing remitting
disease, and active secondary progressive disease, is characterized
by clearly defined attacks of worsening neurologic function.7 These
attacks — often called relapses, flare-ups or exacerbations — are
followed by partial or complete recovery periods (remissions),
during which symptoms improve partially or completely with no
apparent progression of disease.7 RMS is the most common disease
course at the time of diagnosis.7 Approximately 85% of patients are
initially diagnosed with RMS, compared with 10-15% with progressive
forms of the disease.7
About ZEPOSIA® (ozanimod)
ZEPOSIA® is a sphingosine 1-phosphate (S1P) receptor modulator
that binds with high affinity to S1P receptors 1 and 5.1 ZEPOSIA
blocks the capacity of lymphocytes to egress from lymph nodes,
reducing the number of lymphocytes in peripheral blood.1 The
mechanism by which ozanimod exerts therapeutic effects in multiple
sclerosis is unknown but may involve the reduction of lymphocyte
migration into the central nervous system.1
ZEPOSIA is also in development for additional
immune-inflammatory indications, including ulcerative colitis and
Crohn's disease.8,9
Indication
ZEPOSIA is indicated for the treatment of relapsing forms of
multiple sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary progressive
disease, in adults.
IMPORTANT SAFETY INFORMATION
Contraindications:
- Patients who in the last 6 months, experienced myocardial
infarction, unstable angina, stroke, transient ischemic attack
(TIA), decompensated heart failure requiring hospitalization, or
Class III/IV heart failure or have a presence of Mobitz type II
second or third-degree atrioventricular (AV) block, sick sinus
syndrome, or sino-atrial, unless the patient has a functioning
pacemaker
- Patients with severe untreated sleep apnea
- Patients taking a monoamine oxidase (MAO) inhibitor
Infections: ZEPOSIA may increase the susceptibility to
infections. Life-threatening and rare fatal infections have
occurred in patients receiving ZEPOSIA. Obtain a recent (i.e.,
within 6 months or after discontinuation of prior MS therapy)
complete blood count (CBC) including lymphocyte count before
initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with
an active infection until the infection is resolved. Consider
interruption of treatment with ZEPOSIA if a patient develops a
serious infection. Continue monitoring for infections up to 3
months after discontinuing ZEPOSIA
- Herpes zoster was reported as an adverse reaction in
ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella
zoster meningitis have been reported with sphingosine 1-phosphate
(S1P) receptor modulators. Patients without a healthcare
professional-confirmed history of varicella (chickenpox), or
without documentation of a full course of vaccination against
varicella zoster virus (VZV), should be tested for antibodies to
VZV before initiating ZEPOSIA. A full course of vaccination for
antibody-negative patients with varicella vaccine is recommended
prior to commencing treatment with ZEPOSIA
- Cases of fatal cryptococcal meningitis (CM) were reported in
patients treated with another S1P receptor modulator. If CM is
suspected, ZEPOSIA should be suspended until cryptococcal infection
has been excluded. If CM is diagnosed, appropriate treatment should
be initiated.
- Progressive Multifocal Leukoencephalopathy (PML) is an
opportunistic viral infection of the brain that typically occurs in
patients who are immunocompromised, and that usually leads to death
or severe disability. No cases of PML were identified in
active-controlled MS clinical trials with ZEPOSIA. PML has been
reported in patients treated with S1P receptor modulators and other
MS therapies and has been associated with some risk factors. If PML
is suspected, withhold ZEPOSIA and perform an appropriate
diagnostic evaluation. If confirmed, treatment with ZEPOSIA should
be discontinued
- In clinical studies, patients who received ZEPOSIA were not to
receive concomitant treatment with antineoplastic,
non-corticosteroid immunosuppressive, or immune-modulating
therapies used for treatment of MS. Concomitant use of ZEPOSIA with
any of these therapies would be expected to increase the risk of
immunosuppression. When switching to ZEPOSIA from immunosuppressive
medications, consider the duration of their effects and their mode
of action to avoid unintended additive immunosuppressive
effects
- Use of live attenuated vaccines should be avoided during and
for 3 months after treatment with ZEPOSIA. If live attenuated
vaccine immunizations are required, administer at least 1 month
prior to initiation of ZEPOSIA
Bradyarrhythmia and Atrioventricular Conduction Delays:
Since initiation of ZEPOSIA may result in a transient decrease in
heart rate and atrioventricular conduction delays, dose titration
is recommended to help reduce cardiac effects. Initiation of
ZEPOSIA without dose escalation may result in greater decreases in
heart rate. If treatment with ZEPOSIA is considered, advice from a
cardiologist should be sought for those individuals:
- with significant QT prolongation
- with arrhythmias requiring treatment with Class 1a or III
anti-arrhythmic drugs
- with ischemic heart disease, heart failure, history of cardiac
arrest or myocardial infarction, cerebrovascular disease, and
uncontrolled hypertension
- with a history of Mobitz type II second-degree or higher AV
block, sick-sinus syndrome, or sinoatrial heart block
Liver Injury: Elevations of aminotransferases may occur
in patients receiving ZEPOSIA. Obtain liver function tests, if not
recently available (i.e., within 6 months), before initiation of
ZEPOSIA. Patients who develop symptoms suggestive of hepatic
dysfunction should have hepatic enzymes checked and ZEPOSIA should
be discontinued if significant liver injury is confirmed. Caution
should be exercised when using ZEPOSIA in patients with history of
significant liver disease
Fetal Risk: There are no adequate and well-controlled
studies in pregnant women. Based on animal studies, ZEPOSIA may
cause fetal harm. Women of childbearing potential should use
effective contraception to avoid pregnancy during treatment and for
3 months after stopping ZEPOSIA
Increased Blood Pressure: Increase in systolic pressure
was observed after about 3 months of treatment and persisted
throughout treatment. Blood pressure should be monitored during
treatment and managed appropriately. Certain foods that may contain
very high amounts of tyramine could cause severe hypertension in
patients taking ZEPOSIA. Patients should be advised to avoid foods
containing a very large amount of tyramine while taking ZEPOSIA
Respiratory Effects: ZEPOSIA may cause a decline in
pulmonary function. Spirometric evaluation of respiratory function
should be performed during therapy, if clinically indicated
Macular edema: S1P modulators have been associated with
an increased risk of macular edema. Patients with a history of
uveitis or diabetes mellitus are at increased risk. Patients with a
history of these conditions should have an ophthalmic evaluation of
the fundus, including the macula, prior to treatment initiation and
regular follow-up examinations. An ophthalmic evaluation is
recommended in all patients at any time if there is a change in
vision. Continued use of ZEPOSIA in patients with macular edema has
not been evaluated; potential benefits and risks for the individual
patient should be considered if deciding whether ZEPOSIA should be
discontinued
Posterior Reversible Encephalopathy Syndrome (PRES): Rare
cases of PRES have been reported in patients receiving a S1P
receptor modulator. If a ZEPOSIA-treated patient develops
unexpected neurological or psychiatric symptoms or any symptom/sign
suggestive of an increase in intracranial pressure, a complete
physical and neurological examination should be conducted. Symptoms
of PRES are usually reversible but may evolve into ischemic stroke
or cerebral hemorrhage. Delay in diagnosis and treatment may lead
to permanent neurological sequelae. If PRES is suspected, treatment
with ZEPOSIA should be discontinued
Unintended Additive Immunosuppressive Effects From Prior
Immunosuppressive or Immune-Modulating Drugs: When switching
from drugs with prolonged immune effects, the half-life and mode of
action of these drugs must be considered to avoid unintended
additive immunosuppressive effects while at the same time
minimizing risk of disease reactivation. Initiating treatment with
ZEPOSIA after treatment with alemtuzumab is not recommended
Severe Increase in Disability After Stopping ZEPOSIA:
Severe exacerbation of disease, including disease rebound, has been
rarely reported after discontinuation of a S1P receptor modulator.
The possibility of severe exacerbation of disease should be
considered after stopping ZEPOSIA treatment so patients should be
monitored upon discontinuation
Immune System Effects After Stopping ZEPOSIA: After
discontinuing ZEPOSIA, the median time for lymphocyte counts to
return to the normal range was 30 days with approximately 90% of
patients in the normal range within 3 months. Use of
immunosuppressants within this period may lead to an additive
effect on the immune system, therefore caution should be applied
when initiating other drugs 4 weeks after the last dose of
ZEPOSIA
Most common Adverse Reactions (≥ 4%): upper respiratory
infection, hepatic transaminase elevation, orthostatic hypotension,
urinary tract infection, back pain, and hypertension.
For additional safety information, please see the full
Prescribing Information and Medication Guide.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube, Facebook and
Instagram.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, whether ZEPOSIA (ozanimod) for the indication
described in this release will be commercially successful and that
continued approval of ZEPOSIA for such indication described in this
release may be contingent upon verification and description of
clinical benefit in confirmatory trials. No forward-looking
statement can be guaranteed. Forward-looking statements in this
press release should be evaluated together with the many risks and
uncertainties that affect Bristol Myers Squibb’s business and
market, particularly those identified in the cautionary statement
and risk factors discussion in Bristol Myers Squibb’s Annual Report
on Form 10-K for the year ended December 31, 2019, as updated by
our subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, Bristol Myers Squibb
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
1 ZEPOSIA (ozanimod) capsules for oral use. Celgene Corporation.
Full prescribing information. 3/2020. 2 GILENYA (fingolimod)
capsules for oral use. Novartis Pharmaceuticals Corporation. Full
prescribing information. 8/2019. 3 MAYZENT (siponimod) tablets for
oral use. Novartis Pharmaceuticals Corporation. Full prescribing
information. 3/2019. 4 National Multiple Sclerosis Society.
Definition of MS.
www.nationalmssociety.org/What-is-MS/Definition-of-MS. Accessed on
April 15, 2020. 5 National Multiple Sclerosis Society. What is
Myelin?
www.nationalmssociety.org/What-is-MS/Definition-of-MS/Myelin.
Accessed April 15, 2020. 6 National Multiple Sclerosis Society.
What Causes MS?
www.nationalmssociety.org/What-is-MS/What-Causes-MS. Accessed April
15, 2020. 7 National Multiple Sclerosis Society. Types of MS.
www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed April
15, 2020. 8 Celgene. A Phase 3, Multicenter, Open-Label Extension
Study of Oral Ozanimod for Moderately to Severely Active Crohn’s
Disease. Available from
www.clinicaltrials.gov/ct2/show/NCT03467958. NLM identifier:
NCT03467958. 9 Celgene. To Evaluate Efficacy and Long-term Safety
of Ozanimod in Japanese Subjects With Moderately to Severely Active
Ulcerative Colitis. Available from
www.clinicaltrials.gov/ct2/show/NCT03915769. NLM identifier:
NCT03915769.
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