Zeposia Tablets Approved in Scotland to Treat Active RRMS

The Scottish Medicines Consortium (SMC) has approved Zeposia (ozanimod) for the treatment of active relapsing-remitting multiple sclerosis (RRMS).

Zeposia is sold as a tablet, to be taken by mouth once daily.

The SMC has recommended that Zeposia be prescribed for people with RRMS who experience relapses or have evidence of disease activity on brain imaging. It’s also recommended for those who prefer or find it easier to take medications as a tablet.

“This is excellent news,” David Martin, CEO of the U.K. MS Trust, said in a press release.

“The approval of Zeposia in Scotland increases the choices for people with relapsing MS, particularly those who prefer taking a tablet. An expanding range of drugs that work in different ways and have different benefits and risks means more people can find the treatment that is best for them,” Martin said.

The SMC approval follows a recent draft recommendation from the National Institute for Health and Care Excellence (NICE), which opposed the treatment being made available at low or no cost through the National Health Service (NHS) to people with RRMS in England and Wales.

While acknowledging the therapy’s effectiveness, NICE cited a lack of evidence that it slows disability progression more than other MS treatments available. Due to that lack, NICE said that Zeposia cannot be considered a cost-effective treatment at this point.

NICE has requested more data from Zeposia’s developer, Celgene, now a subsidiary of Bristol Myers Squibb. The MS Trust, a charity in England and Wales that advocates for multiple sclerosis patients, announced that it will be replying to NICE’s initial decision.

The public also can reply to NICE’s recommendation. Comments and suggestions regarding this initial decision can be made through NICE’s website until Feb. 12 at 5 p.m. local time (noon EST). Following that deadline, NICE’s appraisal committee will meet to re-evaluate the evidence, review comments submitted, and create a final appraisal document.

Zeposia works by blocking the activity of selective sphingosine 1-phosphate (S1P) receptors. This traps immune cells in immunological structures called lymph nodes, preventing these cells from getting into the nervous system (brain and spinal cord) where they promote inflammation and nerve cell damage.

The medication has been approved to treat active RRMS in the U.S., Canada, and Europe.

These approvals were based on positive findings from two global Phase 3 clinical trials, SUNBEAM (NCT02294058) and RADIANCE part B (NCT02047734).

These Celgene-sponsored trials compared the safety and efficacy of Zeposia to that of Avonex, an approved injectable formulation of interferon beta-1a, marketed by Biogen. Compared with Avonex, Zeposia significantly reduced the rate of relapses and decreased the number of brain lesions, though there were no significant differences between the two treatments in terms of rates of disability progression.

Common side effects associated with Zeposia treatment in clinical trials include nasopharyngitis or the common cold, low white blood cell count, headache, chest infections, and urinary tract infections. The medication also can cause temporary increases in levels of liver enzymes, which generally resolve on their own.