“Our focus at Bristol Myers Squibb is to always put patients at the center of what we do, so we made the difficult decision to delay the ZEPOSIA launch,” said Tina Deignan, vice president and U.S. head of Immunology, Bristol Myers Squibb. “It simply was not the right time to introduce a new therapy to multiple sclerosis patients, who may face a worsening of symptoms in response to infections like COVID-19,2 and were, in many cases, unable to leave their homes to see their doctors.”
In the subsequent weeks, the company closely monitored the environment in partnership with neurologists and the MS community, leading to an announcement on June 1 that ZEPOSIA is now commercially available in the U.S.
“We’re pleased to be able to offer this new treatment option1 to MS patients. There is no one-size-fits-all treatment for MS patients, and this community’s unmet need is still central to every action we take, and we are now turning our focus to making it accessible to all appropriate patients who need it,” Deignan added.
While the mechanism by which ZEPOSIA exerts therapeutic efforts in MS is unknown, the therapy may involve reducing lymphocyte (a type of white blood cell important to the immune system) movement from lymph nodes into the central nervous system, reducing the number of lymphocytes in peripheral blood. ZEPOSIA targets sphingosine-1-phospate (S1P) receptors with selectivity.1
ZEPOSIA is the only approved S1P receptor modulator that offers relapsing forms of MS patients an initiation with no genetic test and no label-based first-dose observation required for patients.1,3,4 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 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
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. 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 new therapy is launching with a support program – ZEPOSIA 360 Support™. The program offers support and many different financial options to participating appropriate adult patients with MS. This includes a co-pay of as little as $0 for eligible appropriate patients, assistance with financial support, reimbursement for some out-of-pocket medical costs – and a bridge program that may help appropriate patients with commercial insurance to receive free medication while they are waiting for insurance approvals. Dedicated MS Nurse Navigators will help ZEPOSIA MS patients schedule key appointments, understand insurance benefits, and assist with financial support. Terms, conditions, and eligibility criteria apply. More information is available at ZEPOSIA.com.
“Multiple sclerosis is a devastating neurological disease. We are committed to leveraging our Immunology expertise to do all we can to ensure this innovative compound ultimately benefits as many patients as possible,” said Deignan.