The US Food and Drug Administration (FDA) has approved a new drug, siponimod, to treat MS.
The FDA decision approves the drug to be used for relapsing forms of MS, including for people with secondary progressive MS who continue to experience relapses (a phase described as active secondary progressive MS).
This follows successful trials showing that siponimod slowed disability progression and reduced inflammatory activity.
Siponimod is currently being reviewed by the European Medicines Agency (EMA), the body responsible for drug licensing in Europe. A decision is expected later this year.
Siponimod is an immune modulating drug, taken as a pill, once a day.
Professor Xavier Montalban, Chair of the International Medical and Scientific Board for MS International Federation, commented:
‘This is another important step in our efforts to make sure that all types of MS can be treated effectively.
‘Each new drug that is developed and approved not only gives us a new treatment option for people with MS; it helps us to understand MS better. Of course we still have much work to do, but piece by piece we are unravelling this disease and making strides towards our ultimate goal of stopping MS.’
In many countries, people with secondary progressive MS who still have signs of inflammatory activity can continue with existing treatments for relapsing MS. Siponimod’s approval by the FDA specifically applies to these people, as well as those with other forms of relapsing MS.
Some countries do not allow drugs that have been approved for relapsing MS to also be used to treat secondary progressive MS. Siponimod could provide a new treatment option for those living with active secondary progressive MS.
The clinical trials tested siponimod against placebo, not against other treatments. The largest (Phase 3) trial was conducted across 31 countries. When enrolled into the study, trial participants had been living with MS for an average of 17 years, and had an average age of 48.
Read the FDA’s announcement here.