The Food and Drug Administration (FDA) approved ozanimod (Zeposia; Bristol Myers Squibb, Princeton, NJ) for treatment of relapsing forms of multiple sclerosis (MS) on March 25, 2020. Ozanimod, 0.92 mg, is a new once-daily oral medication for adults with relapsing MS.
Ozanimod is the only approved sphingosine-1-phosphate (S1P) receptor modulator that can be initiated without genetic testing or first-dose observation. Ozanimod should be started at a low dose and titrated upward to a maintenance dosage because transient decrease in heart rate and atrioventricular conduction decrease may occur. Before starting ozanimod, all individuals need a recent complete blood cell count including lymphocytes, within the last 6 months or after discontinuation of prior MS therapy; ECG to check for any conduction abnormalities; and a recent liver function test. Current and prior medications should be considered before prescribing ozanimod. For anyone with a history of uveitis or macular edema, an ophthalmic assessment is required.
“We are pleased to now bring ozanimod, an important new once daily treatment option, to RMS patients,” said Tina Deignan, vice president and US head of immunology, Bristol Myers Squibb. “Ozanimod is the first and only S1P that requires no first dose observation, which may minimize the number of interactions RMS patients need to have with healthcare practitioners prior to initiating therapy during this unprecedented time of social distancing.”
Treatment with ozanimod also carries a higher risk of infection, increased blood pressure, respiratory effects, and posterior reversible encephalopathy syndrome. Ozanimod discontinuation carries risks of immune system effects and a severe increase in disability and should not be used in pregnancy because of risks to the fetus.
The most common adverse reactions in clinical trials (incidence ≥ 4%) were upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.