EC approved Aubagio as the first oral MS therapy for RRMS, based on data from the Phase 3 TERIKIDS trial in 166 participants
Sanofi’s Aubagio approved in EU to treat RRMS. (Credit: Raman Oza from Pixabay.)
Sanofi has received the European Commission (EC) approval for its Aubagio (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) in patients aged 10 to 17 years.
Aubagio was initially approved in the European Union (EU) in 2013 for the treatment of adults with RRMS.
With the current approval, Aubagio becomes the first oral multiple sclerosis (MS) therapy in the EU, indicated for the first-line treatment of children and adolescents with MS.
MS is a rare, chronic neurodegenerative disease, which involves a person’s immune system causing damage to the brain and spinal cord.
Also, the EC approval for the paediatric indication expands the marketing protection for the drug for an additional year in the EU.
Sanofi Genzyme neurology development therapeutic area head Erik Wallström said: “Pediatric multiple sclerosis remains an area of significant unmet medical need.
“The European approval of Aubagio in paediatrics means young people with MS have a new treatment option, and importantly – one that can offer meaningful improvement in managing this serious disease.”
The EC approved of Aubagio is based on data from the TERIKIDS, a Phase 3 multicentre, randomised, double-blind, placebo-controlled, parallel-group trial, in 166 RRMS patients.
Time to first confirmed clinical relapse, with prespecified sensitivity analysis including magnetic resonance imaging (MRI) activity as relapse equivalent was the primary endpoint.
In the study, the primary endpoint was not statistically significant with numerically a lower risk of clinical relapse for teriflunomide compared to placebo.
The drug significantly reduced the number of T1 gadolinium (Gd)-enhancing lesions per MRI scan along with new and enlarging T2 lesions per MRI scan, a key secondary endpoint.
In the study, teriflunomide was well tolerated and had a manageable safety profile in the paediatric population.
The overall adverse events (AEs) and serious adverse events (SAEs) in the study were similar in both teriflunomide and the placebo groups, with no deaths reported.