First therapy to treat pediatric MS approved in US
Fingolimod has been approved by the US Food and Drug Administration (FDA) as a treatment for children and young people aged 10 years and older with relapsing MS
Last updated: 17th May 2018
Fingolimod has been approved by the US Food and Drug Administration (FDA) as a treatment for children and young people aged 10 years and older with relapsing MS. This is the first therapy that has been approved in the US to treat pediatric MS.
This approval is based on phase III trial results from the PARADIGM study, which showed that fingolimod reduced the annual number of relapses by 82% over two years.
The PARADIGM study was designed in collaboration with the International Pediatric Multiple Sclerosis Study Group (IPMSSG), the FDA and the European Medicines Agency (EMA).
The IPMSSG has played an important role in advocating for access to safe and effective treatments, approved by regulatory bodies for use in children with MS. From 2006 to 2016, MS International Federation (MSIF) provided the IPMSSG with administrative leadership, support, advice to the steering committee and contributed funding for various events, activities and publications. The global MSIF movement continues to support every effort to improve the information and access to safe and effective treatments for children and families affected by MS.