Zeposia, Daily Oral Treatment for Relapsing MS, Now Available in US

Zeposia (ozanimod), a newly approved oral capsule treatment for relapsing forms of multiple sclerosis (MS), is now commercially available in the United States, its manufacturer, Bristol Myers Squibb, announced.

“We are pleased to now bring Zeposia, an important new once daily treatment option, to [relapsing] MS patients,” Tina Deignan, vice president and U.S. head of immunology at Bristol Myers Squibb, said in a press release.

Zeposia was approved by the U.S. Food and Drug Administration (FDA) in March to treat relapsing MS, which includes relapsing-remitting MS (RRMS), active secondary progressive MS (SPMS), and clinically isolated syndrome (CIS). It is an oral sphingosine-1-phosphate (S1P) receptor modulator, a type of medication that works by trapping immune cells in lymph nodes (immune system structures), thereby preventing these cells from damaging the nervous system.

Other approved S1P receptor modulators include Novartis‘ Gilenya (fingolimod) and Mayzent (siponimod), both also oral therapies. Because Zeposia is more selective for certain types of S1P receptors — specifically S1P receptors type 1 and type 5 — it is thought to have a better safety profile than Gilenya.

According to Bristol Myers Squibb, Zeposia is currently the only S1P receptor modulator that does not require a genetic test or an observation period for most patients being given the first dose. Owing to a risk of heart-related side-effects, including a transient decrease in heart rate, first-dose monitoring might be required for people with certain pre-existing heart conditions.

“Zeposia is the first and only S1P [receptor modulator] that requires no first dose observation, which may minimize the number of interactions [relapsing] MS patients need to have with healthcare practitioners prior to initiating therapy during this unprecedented time of social distancing,” Deignan said, referring to the ongoing COVID-19 pandemic.

Prior to treatment with Zeposia, patients are required to complete certain medical tests, including blood tests, analyses of heart and liver function, and an assessment of current and previous medications. People with a history of certain eye problems — namely, uveitis or macular edema — also need an eye examination before starting with Zeposia.

The medication is given at a recommended dose of 0.92 mg, taken daily. During the first week of treatment, an up-titration scheme — where a patient is started at a lower dose, then gradually increased to 0.92 mg per day — is necessary in order to minimize the risk of heart-related side-effects, the FDA’s label for this treatment states.

Zeposia is generally safe and well-tolerated, and has been shown to reduce the annual relapse rate and the number of brain lesions detectable via MRI in treated patients.

Bristol Myers Squibb opened a patient assistance program, Zeposia 360 Support, to help people with relapsing MS access to this medication and use it properly. This aid includes financial assistance for certain individuals, as well as a program to help those with commercial insurance get the medication while they wait for insurance approvals.

Zeposia was also recently approved by the European Commission for the treatment of active RRMS.

It was developed by Celgene, a subsidiary of Bristol Myers Squibb.