Posted by Michael Wonder on 26 Mar 2019
Novartis receives FDA approval for Mayzent (siponimod), the first oral drug to treat secondary progressive MS with active disease
26 March 2019 - Novartis today announced that the US FDA has approved Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple sclerosis with active disease, relapsing remitting multiple sclerosis and clinically isolated syndrome.
Secondary progressive multiple sclerosis is a debilitating form of multiple sclerosis characterised by progressive and irreversible neurological disability. Mayzent is expected to be available in the US in approximately one week. Patients will not require a first dose observation (FDO, cardiac monitoring upon initiation) unless they have certain pre-existing cardiac conditions.
Novartis is committed to bringing Mayzent to patients worldwide, and additional regulatory filings are currently underway with other health authorities outside the US. Regulatory action for Mayzent in the European Union is anticipated in late 2019, with additional regulatory action anticipated in Switzerland, Japan, Australia and Canada this year.
