PRINCETON -
ZEPOSIA, an oral medication taken once daily, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients.1,4,5 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
Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell.6,7 This 'signal breakdown' can lead to symptoms and relapses.6,8
'With the FDA approval of ZEPOSIA, appropriate patients with relapsing forms of multiple sclerosis will have another oral treatment option with meaningful efficacy to help address the disease's hallmark relapses and brain lesions,'9 said
The approval is based on data from the largest pivotal, head-to-head RMS studies with an active comparator to date: the randomized, active-controlled Phase 3 SUNBEAM (safety and efficacy of ZEPOSIA versus interferon beta-1a in relapsing multiple sclerosis) and RADIANCE (safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ZEPOSIA in relapsing multiple sclerosis) Part B clinical trials of more than 2,600 adults.1,2,3,10 In both trials - as compared to
ZEPOSIA demonstrated a relative reduction in ARR versus
At one year, treatment with ZEPOSIA reduced the number of T1-weighted gadolinium-enhanced (GdE) brain lesions more than
At two years, treatment with ZEPOSIA reduced the number of T1-weighted gadolinium-enhanced (GdE) brain lesions more than
There was no statistically significant difference in the three-month and six-month confirmed disability progression between ZEPOSIA- and
ZEPOSIA demonstrated acceptable safety and tolerability in the Phase 3 SUNBEAM and RADIANCE Part B trials.1,2,3 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 The most common adverse reactions (incidence 4%) were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.1
Before initiation of treatment with ZEPOSIA, all patients require assessments including a recent complete blood count including 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
'Treatment for relapsing forms of multiple sclerosis is critical to address this devastating neurological disease.11 I'm excited, with the introduction of ZEPOSIA, I will have a new oral option to offer my RMS patients that has demonstrated efficacy and safety,'1 said
'Multiple sclerosis is an unpredictable and often disabling disease that affects nearly one million people in the United States.9,12 Ongoing treatment with disease-modifying therapy can reduce the number of disease attacks,'11 said
As the country's healthcare system is dealing with the unprecedented COVID-19 pandemic,
A Marketing Authorization Application for ZEPOSIA for the treatment of adults with relapsing-remitting multiple sclerosis in the
About SUNBEAM
SUNBEAM is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral ZEPOSIA (0.92 mg, equivalent to 1 mg) against weekly intramuscular
The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period.3 The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months and number of gadolinium-enhanced brain MRI lesions at month 12.3
An analysis of the time to onset of three-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.1,2,3
About RADIANCE
RADIANCE Part B is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of oral ZEPOSIA (0.92 mg, equivalent to 1 mg) against weekly intramuscular
The primary endpoint of the trial was ARR over 24 months.2 The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months.2
An analysis of the time to onset of three-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.1,2,3
About Multiple Sclerosis
Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves.6 The myelin damage disrupts communication between the brain and the rest of the body.7 Ultimately, the nerves themselves may deteriorate - a process that's currently irreversible.13
RMS, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, is characterized by clearly defined attacks of worsening neurologic function.14 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.14 RMS is the most common disease course at the time of diagnosis.14 Approximately 85% of patients are initially diagnosed with RMS, compared with 10-15% with progressive forms of the disease.14
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 blood1 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.15,16
About
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
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