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Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

Sanofi’s oral therapy Aubagio has been approved by the European Commission (EC) for the treatment of children and adolescents with relapsing-remitting multiple sclerosis (RRMS). 

The EC has cleared Aubagio (teriflunomide) as a first-line treatment for paediatric RRMS patients who are ten to 17 years old.

The approval is based on the phase 3 TERIKIDS clinical trial, evaluating the safety and efficacy of Aubagio in paediatric patients with relapsing forms of MS.

The study consisted of a screening period of up to four weeks followed by a double-blind treatment period, with up to 96 weeks of randomisation. The study participants either received Aubagio, at a dose equivalent to 7mg in adults during the first eight weeks followed by 14mg, or a placebo.

Data from this study showed that Aubagio cut the risk of MS relapses by 34% in the first 96 weeks of treatment and prolonged the median time to first confirmed relapse to 75.3 weeks compared with 39.1 weeks for placebo – although this difference was not statistically significant.

Aubagio was also found to reduce the risk of high disease activity by 43% versus placebo, significantly prolonging the media time until the first indications of disease activity – 72.1 weeks for Aubagio versus 37.0 weeks for placebo.

Key secondary endpoints showed that Aubagio significantly reduced the number of new or enlarging MRI lesions in children, with a relative risk reduction of 75% for T1 lesions and 55% for T2 lesions.

An open-label TERIKIDS phase 3 trial extension is still ongoing.

“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,” said Erik Wallström, therapeutic area head, neurology development at Sanofi Genzyme.

Earlier this month, the US Food and Drug Administration (FDA) rejected a label expansion for Aubagio in the same patient population, opting not to approve the oral therapy for the treatment of paediatric patients who are ten to 17 years old with relapsing forms of MS.

In a statement, Sanofi said the FDA deemed that the data submitted for Aubagio in this setting was not sufficient to obtain approval ‘at this time’.

Article by
Lucy Parsons

21st June 2021

From: Regulatory



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