On March 26, 2020, Bristol Myers Squibb announced that the United States Food and Drug Administration (FDA) approved Zeposia® (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary-progressive MS (SPMS). Zeposia is an oral medication given once daily as a 0.92 mg pill.
Patients taking Zeposia for the first time start with a titration, which means that it is begun at a lower dose and gradually increased until the full dose is reached. With this newly approved medication, starting at a lower dose reduces the risk of a transient decrease in heart rate and atrioventricular conduction delays, which may occur if a larger dose is introduced too quickly.
Zeposia is a sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It joins two other previously approved S1P receptor modulators: Gilenya® (fingolimod) and Mayzent® (siponimod); additional S1P receptor modulators are also under investigation. Ponesimod is among those still under investigation and it was recently submitted to the FDA for approval. According to the manufacturer, Zeposia is the only approved S1P receptor modulator that offers RMS patients an initiation that does not require a genetic test or label-based first-dose observation.
S1P receptor modulators are thought to work by blocking potentially damaging immune-system cells (lymphocytes) from leaving lymph nodes, lowering their number in the blood and tissues. These treatments may reduce damage to the central nervous system (CNS). In clinical trials of more than 2,600 adults with relapsing forms of MS, Zeposia was shown to have a significant effect on reducing the annual relapse rate (ARR) as well as the number of brain lesions, when compared to Avonex® (interferon beta-1a).
Bristol Myers Squibb is delaying the launch of Zeposia and released the following statement, “As the country’s healthcare system is dealing with the unprecedented COVID-19 pandemic, Bristol Myers Squibb has made the decision to delay commercialization of Zeposia. The Company made the decision based on what’s in the best health interest of our patients, customers and employees. Bristol Myers Squibb will continue to monitor the environment and will partner with the neurology community to inform launch timing.” MSAA will inform the MS community of a launch date once it is announced.
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