The European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease based on clinical or imaging features.
The EC decision follows a positive opinion issued in March by the European Committee for Medicinal Products for Human Use (CHMP).
“Today’s European Commission approval provides the opportunity for patients with RRMS with active disease to be offered Zeposia as a new first-line treatment option,” Samit Hirawat, MD, chief medical officer at Bristol Myers Squibb (BMS), Zeposia’s manufacturer, said in a press release.
“We share this achievement with the courageous multiple sclerosis patient community in Europe and around the globe, and are working closely with all stakeholders to ensure that eligible European patients can start benefitting from Zeposia as quickly as possible,” Hirawat said.
Zeposia is a sphingosine-1-phosphate (S1P) receptor modulator, a type of medication that works by trapping immune cells in lymph nodes (structures of the immune system). This prevents immune cells from entering the nervous system, where they can promote further inflammation and nerve cell damage.
Other medications in this class include Gilenya (fingolimod) and Mayzent (siponimod), both by Novartis. Because Zeposia is more selective for certain kinds of S1P receptors — namely S1P receptors types 1 and 5 — it is believed that it may have a better safety profile than Gilenya.
According to BMS, Zeposia is the only oral S1P receptor modulator that is approved for people with active RRMS without the need for first-dose monitoring in most cases — such monitoring is required only for high-risk individuals with specific pre-existing heart conditions because a transient decrease in heart rate may occur.
The oral medication is given in escalating doses over the first week of treatment up to the recommended maintenance dose of 0.92 mg per day, in order to minimize the risk of heart problems.