FDA approves Zeposia, a new oral treatment for relapsing MS

March 26, 2020
The U.S. Food and Drug Administration approved Zeposia® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia, an oral medication taken once daily.

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 MS) and RADIANCE (safety and efficacy of the selective sphingosine 1-phosphate receptor modulator Zeposia in relapsing MS) Part B clinical trials of more than 2,600 adults. In both trials – as compared to Avonex (interferon beta-1a), Zeposia delivered powerful efficacy as measured by annualized relapse rate, as well as on the number and size of brain lesions.
  • Zeposia demonstrated a relative reduction in ARR versus Avonex of 48 percent through one year and 38 percent at two years.
  • At one year, treatment with Zeposia reduced the number of T1-weighted gadolinium-enhanced brain lesions more than Avonex, a relative reduction of 63 percent, and reduced the number of new or enlarging T2 lesions, a relative reduction of 48 percent.
  • At two years, treatment with Zeposia reduced the number of T1-weighted gadolinium-enhanced brain lesions more than Avonex, a relative reduction of 53 percent. Zeposia also reduced the number of new or enlarging T2 lesions vs Avonex, a relative reduction of 42 percent.

There was no statistically significant difference in the three-month and six-month confirmed disability progression between Zeposia- and Avonex-treated patients over two years.

Zeposia demonstrated acceptable safety and tolerability in the Phase 3 SUNBEAM and RADIANCE Part B trials. Zeposia is not indicated in patients who in the last six months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, 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 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. 

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. The most common adverse reactions were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.

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. For patients with a history of uveitis or macular edema, an ophthalmic assessment is required.

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