Wednesday, March 27, 2019

Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease.

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) -
~~~~~~~~~~~~~~~~~~~

- Mayzent® (siponimod) is the first and only oral treatment 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
- 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)
- 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




NEWS PROVIDED BY





                      
Article Provided by:  #MSViewsandNews
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

No comments:

Post a Comment

Thank You for leaving a comment.
Attempts to redirect viewers of this blog to another website and / or any marketing, will be removed.

Note: Only a member of this blog may post a comment.