Mayzent, developed by Novartis, is a tablet taken once daily to counter a person’s disability progression. SPMS gradually develops from relapsing-remitting MS, and is characterized by increasing disability, such as fatigue, bladder and bowel dysfunction, and problems with coordination and balance, among others.
Active SPMS is characterized by relapses and/or new and active brain lesions on MRI scans.
“At the moment there are few options for someone whose MS is changing from relapsing remitting to secondary progressive, so this approval is very welcome and a big step forward,” David Martin, CEO of the U.K. MS Trust, said in a press release.
The MS Trust is a patient advocacy organization that helped ease the path toward Mayzent’s approval by surveying roughly 400 people affected by SPMS about the challenges of living with the disease. The Trust included the patients’ accounts in a submission to the SMC, concerning the decision.
In clinical trials, Mayzent slowed disability progression by 26% in SPMS patients, compared to placebo, and by 37% in patients with active SPMS.
Mayzent also significantly improved participants’ cognitive processing speed and reduced the risk of cognitive worsening. Benefits to memory also were reported.
“By slowing down disability progression and improving cognition, siponimod has the potential to allow people to carry on working, remain independent and stay connected with family and friends. More broadly, we hope that the availability of this new treatment will lead to a greater focus on services for progressive MS which would benefit a much wider group of people,” Martin said.
Mayzent works by binding to the sphingosine-1-phosphate receptor found on the outside of immune cells, preventing these cells from entering circulation and attacking the myelin sheaths protecting neurons. Loss of myelin is a hallmark of MS.
The National Institute for Health and Care Excellence (NICE) recently recommended against approving Mayzent for use in England and Wales, citing its unknown cost effectiveness compared to an existing therapy.
NICE noted in its opinion that trial data did not include a direct comparison between Mayzent and interferon beta-1b (sold in Europe as Betaferon and Extavia), which, prior to the SMC’s decision, had been the only available treatment for SPMS in the U.K.
The current SMC decision applies only to Scotland.
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