Following the news that the European Commission approved Novartis’ Mayzent to treat patient with secondary progressive multiple sclerosis (SPMS);

Alessio Brunello, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his view:

“Mayzent (siponimod) is Novartis’ second-generation S1P receptor modulator, which has a mechanism of action (MOA) similar to Gilenya, but specifically targets S1P1 and S1P5 whereas Gilenya is a non-specific inhibitor across different subtypes of S1P receptors. It has been approved in March 2019 for the treatment of Relapse-Remitting MS (RRMS) and SPMS in US and it is currently in pre-registration in Japan where is expected to be launched later this year.

“There are currently no approved drugs specifically designed for SPMS. Beta-interferons have been approved to treat SPMS in some European countries, but their efficacy is not convincing. Mazyent demonstrated more robust efficacy than beta-interferons, and can therefore potentially fulfil an important unmet need in MS by providing a much-needed additional treatment option for patients with SPMS.

“Mazyent will be an important market entrant for the EU MS market for the treatment of SPMS, an indication in which current treatment options are limited for patients. As such, Mayzent will face limited competition at launch, and GlobalData expects the product to experience rapid uptake.

“GlobalData expects global sales for Mazyent to reach approximately $1.8bn in the seven major markets (7MM*) by the end of 2028. This is approximately half of the peak sales reached by Novartis’ Gilenya, due to progressive MS being a smaller patient segment compared to RRMS. Mayzent will also face direct competition from masitinib and ofatumumab, which are expected to reach the progressive MS market in 2021.”

*7MM = US, France, Germany, Italy, Spain, UK and Japan