Following the news that Novartis’ Mayzent (siponimod) has been approved in the US, becoming the first drug approved for patients with active secondary progressive multiple sclerosis (SPMS) in over 15 years and the first oral formulation,

Mark Needham, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“This is a landmark approval for SPMS patients, with a treatment that can delay the progression of disability and preserve cognition in this underserved treatment population. Mayzent is the first second-generation sphingosine 1-phosphate (S1P) receptor modulator to enter the MS market and has the same mechanism of action as Gilenya, which generated $3.34bn in 2018.

“Mayzent is more receptor-specific than Gilenya, which improves efficacy and reduces cardiac side effects. Based on this we expect Mayzent to generate $1.79bn in sales by 2026 in the 7MM*. Approval was granted based on data from the Phase III EXPAND trial, with results showing that Mayzent significantly reduced the risk of three-month confirmed disability progression in patients with active disease by 21%, compared with placebo. The drug also reduced the annualised relapse rate by 55%.

“A potential source of commercial competition for Mayzent could come from drugs with greater efficacy for relapsing-remitting MS (RRMS), which will likely delay the transition of RRMS patients to SPMS, thus limiting Mayzent’s potential treated population.”

‘*’ 7MM = US, 5EU (France, Germany, Italy, Spain, and the UK) and Japan.