Bristol Myers Squibb announced that ZEPOSIA, 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.
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
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.