Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease. This was also approved for RRMS and CIS (Clinically Isolated Syndrome) –
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– Mayzent® (siponimod) is the first and only oral treatment
specifically indicated for active secondary progressive multiple sclerosis
(SPMS) in adults
specifically indicated for active secondary progressive multiple sclerosis
(SPMS) in adults
– Up to 80% of patients with relapsing remitting MS (RRMS) will
develop SPMS(1); Mayzent addresses a critical unmet need for RRMS patients in
transition and those with active SPMS who have transitioned
develop SPMS(1); Mayzent addresses a critical unmet need for RRMS patients in
transition and those with active SPMS who have transitioned
– Approval is based on the Phase III EXPAND trial, the largest
controlled clinical study of SPMS patients, showing Mayzent significantly
reduced the risk of three-month confirmed disability progression in patients
with active disease(2)
controlled clinical study of SPMS patients, showing Mayzent significantly
reduced the risk of three-month confirmed disability progression in patients
with active disease(2)
– Mayzent is approved across the MS spectrum for clinically
isolated syndrome (CIS), RRMS and active SPMS, with most patients not requiring
a first dose observation
isolated syndrome (CIS), RRMS and active SPMS, with most patients not requiring
a first dose observation
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