Novartis announces EU approval of Mayzent (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS) with active disease
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
Jan 20, 2020
- Mayzent??(siponimod) is the first and only oral treatment specifically indicated for patients with secondary progressive multiple sclerosis (SPMS) with active disease in Europe1
- Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population
- Approval is based on the Phase III EXPAND trial, the largest randomized clinical study in a broad range of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including physical disability and cognitive decline2,3
The digital press release with multimedia content can be accessed here:
Basel, January 20, 2020?? Novartis today announced the European Commission (EC) has approved Mayzent??(siponimod) for the treatment of adult patients with secondary progressive multiple sclerosis (SPMS) with active disease evidenced by relapses or imaging features of inflammatory activity. Although every patient?s MS journey is unique, up to 80% of relapsing remitting MS (RRMS) patients will eventually transition to SPMS4. Mayzent addresses an unmet need for SPMS patients with active disease who, until now, did not have an oral treatment that has been shown to be effective in delaying progression in this patient population. The European marketing authorization makes Mayzent the first and only indicated oral treatment proven in SPMS patients with active disease based on a randomized clinical trial of a broad range of SPMS patients. ?We are delighted by the news that there is now a treatment available for people in Europe living with active SPMS to potentially delay the progression of this debilitating disease,? said Pedro Carrascal, President of the European MS Platform. ?This treatment brings hope for improved care and quality of life to patients who have long been underserved.? The EC?s approval is based on data from the EXPAND study, a randomized, double-blind, placebo-controlled trial, comparing the efficacy and safety of Mayzent versus placebo in a broad range of SPMS patients (EDSS score 3?0?6?5 at baseline). EXPAND included a subgroup of patients with active disease (n=779), defined as patients with relapses in the two?years prior to the study and/or presence of Gd-enhancing T1 lesions at baseline. The baseline characteristics were similar except for signs of activity compared to the overall population. In the subgroup of Mayzent-treated patients with active disease, results showed:- The risk of three-month and six-month confirmed disability progression (CDP) was significantly reduced by 31% compared to placebo and by 37% compared to placebo, respectively5.
- Significant favorable outcomes in other relevant measures of MS disease activity, including annualized relapse rate (ARR ? confirmed relapses), MRI disease activity and brain volume loss (brain shrinkage)5.