Zeposia (ozanimod) was initially denied approval back in 2018 when the drugmaker Celgene (now part of Bristol Myers Squibb) submitted to the regulatory body. The grounds for denial lay in the company’s lack of sufficient pharmacology information in its original application. The medication acts as a sphingosine-1-phosphate (S1P) receptor modulator, which indirectly “antagonizes” these receptors’ function and keeps lymphocytes — white blood cells that appear to be associated with MS attacks — from leaving the lymph nodes. When compared with interferon beta-1a (Avonex) in a study published in September 2019 in The Lancet, the drug showed better efficacy at preventing both relapses and the numbers of certain types of brain lesions.
Contraindications and Side Effects
There are a number of contraindications (situations in which a drug should not be used because it may be harmful) in relation to patients with specific cardiac issues. The most common side effects of Zeposia were reported to be respiratory infection, elevated liver enzymes, decreased systolic blood pressure when standing (orthostatic hypotension), urinary tract infection, back pain, hypertension, and viral rash (herpes zoster).
Commercialization Delayed by Global Pandemic
Due to the current health crisis, however, Bristol Myers Squibb said in its announcement of approval that the company has made “the decision to delay commercialization of Zeposia.” They intend to consult with the neurology community as the public health situation evolves to produce and launch the new MS drug at a more appropriate time. It appears that even the release of new disease-modifying drugs for multiple sclerosis are being directly affected by the COVID-19 coronavirus pandemic. Wishing you and your family the best of health. Cheers, Trevis