Gilenya (fiongolimod ) is the first disease modifying therapy to be recommended for licensing for young people with MS.
Reduction of relapses and lesions
Researchers showed that Gilenya significantly reduced the number of relapses experienced by people aged 10-17 with MS, compared to those taking beta-interferons.
It also reduced the number of new lesions found on MRI scans, but did have serious side effects for some people.
The study involved 215 children and adolescents between the ages of 10 and 17 in 25 different countries, including the UK. The PARADIGMS trial results were published in the New England Journal of Medicine.
Recommended for licensing
Gilenya is already approved as a treatment for adults with MS. Now the Committee for Medicinal Products for Human Use (CHMP) has recommended that it be licensed for those aged 10-17 too.
The European Medical Agency (EMA) is expected to make a decision by the end of the year.
Dr Susan Kohlhaas, our Director of Research, said:
“It’s really encouraging to see that Gilenya can reduce relapses in young people living with MS, and we look forward to a decision soon from the EMA on its licensing. We’re hopeful that, if licensed, Gilenya will be made available as a treatment choice to those who could benefit from it as quickly as possible.”
More treatments needed for children with MS
Although it is rare for children to develop MS, many experience more frequent relapses than people diagnosed as adults.
About a third of young people with MS also experience cognitive impairment that can affect their relationships and school performance.
Susan added: “While we’re driving research into more – and better – treatments all the time, there is still a need for effective MS treatments for people under 18.”