US and European regulators have accepted marketing applications from Novartis for once-daily siponimod (BAF312), for the treatment of secondary progressive multiple sclerosis in adults.
Novartis used a priority review voucher in the USA to speed up the review of the drug, and a decision is expected in March next year. In Europe, a decision is expected by the end of 2019.
The application is based on the Phase III EXPAND study. Results showed siponimod significantly reduced the risk of three-month confirmed disability progression compared with placebo.
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