European Commission approves Aubagio® (teriflunomide) as the first
oral MS therapy for first-line treatment of children and
adolescents living with relapsing-remitting multiple sclerosis
European Commission approves
Aubagio® (teriflunomide) as the
first oral MS therapy for first-line treatment of children and
adolescents living with relapsing-remitting multiple
sclerosis
PARIS –
June 18,
2021 - The European Commission (EC) has
approved Aubagio® (teriflunomide) for the treatment of pediatric
patients 10 to 17 years of age with relapsing-remitting multiple
sclerosis (RRMS). The EC approval is based on data from the Phase 3
TERIKIDS study. The approval confirms Aubagio as the first oral
multiple sclerosis (MS) therapy for first-line treatment of
children and adolescents with MS in the European Union.
MS affects an estimated 2.8 million people
around the world, with children and adolescents representing at
least 30,000 of those impacted.1,2 Pediatric MS is a rare condition
and onset follows a relapsing-remitting disease course in 98
percent of pediatric patients.3,4 Compared with adult-onset MS,
pediatric patients often present with higher relapse rates and a
greater lesion burden.5 Due to the earlier onset of disease,
irreversible disability and secondary progression often occur at an
earlier age than with adult counterparts.3 The symptoms of MS can
impact all aspects of a young person’s life from physical health to
social development and self-esteem.6“Pediatric multiple sclerosis
remains an area of significant unmet medical need,” said Erik
Wallström, MD, PhD, Therapeutic Area Head, Neurology Development at
Sanofi Genzyme. “The European approval of Aubagio in pediatrics
means young people with MS have a new treatment option, and
importantly - one that can offer meaningful improvement in managing
this serious disease.” Aubagio was initially approved in the EU in
2013 for the treatment of adult patients with RRMS and the EC
approval for the pediatric indication provides an additional year
of marketing protection in the European Union.
Aubagio Efficacy and Safety in Pediatric
Patients
The Phase 3 TERIKIDS study is a multicenter,
randomized, double-blind, placebo-controlled, parallel-group trial
that enrolled 166 pediatric patients with relapsing-remitting forms
of MS across 22 countries worldwide. The study consisted of a
screening period (up to four weeks), followed by a double-blind
treatment period (up to 96 weeks after randomization). An
open-label TERIKIDS Phase 3 trial extension is ongoing. The primary
endpoint was time to first confirmed clinical relapse, with
prespecified sensitivity analysis including time to high magnetic
resonance imaging (MRI) activity as relapse equivalent.
Additionally, patients who completed the double-blind period, or
had high MRI activity, were eligible to continue into the
open-label extension.
The primary efficacy results and safety and
tolerability data from the double-blind core study period (up to 96
weeks after randomization) were initially presented at the 2020 EAN
Virtual Congress.
In the study, 109 and 57 patients were
randomized to teriflunomide and placebo, respectively.
The primary endpoint was not statistically
significant with numerically a lower risk (-34%) of clinical
relapse for teriflunomide vs placebo (median time: 75.3 vs 39.1
weeks; HR [95% CI] 0.66 [0.39, 1.1] P=0.29). Switches from
double-blind to open-label treatment due to high MRI activity were
more frequent than anticipated. Switches were more frequent and
earlier in the placebo group vs teriflunomide (26% and 14%,
respectively). This decreased study power for the primary
endpoint.
In the pre-specified sensitivity analysis of the
composite endpoint of time to first clinical relapse or high MRI
activity meeting study criteria to switch to open label,
teriflunomide significantly reduced the time to clinical relapse or
switch due to high MRI activity by 43% relative to placebo (median
time: 72.1 vs 37.0 weeks; HR [95% CI] 0.57 [0.37, 0.87]
P=0.04).
Key secondary endpoints showed teriflunomide
significantly reduced the number of T1 gadolinium (Gd) -enhancing
lesions per MRI scan (relative reduction 75%; P<0.0001) as well
as the number of new and enlarging T2 lesions per MRI scan
(relative reduction 55%, P=0.0006).
In the study, teriflunomide was well tolerated
and had a manageable safety profile in the pediatric population.
The overall incidences of adverse events (AEs) and serious adverse
events (SAEs) were similar in the teriflunomide group and the
placebo group (88.1% vs 82.5%, and 11.0% vs 10.5%), respectively.
There were no deaths in the study. AEs reported more frequently in
the teriflunomide group than the placebo group (with a difference
of ≥ 5%) included nasopharyngitis, upper respiratory tract
infection, alopecia, paresthesia, abdominal pain, and increased
blood creatine phosphokinase (≥ 3 times the upper limit of normal).
Cases of pancreatitis were reported in 1.8% (2/109) of the
teriflunomide-treated patients compared to none in the placebo
group, in the double-blind phase. In pediatric patients treated
with teriflunomide in the open-label phase of the study, two
additional cases of pancreatitis and one case of serious acute
pancreatitis (with pseudo-papilloma), were reported.
For more information on the TERIKIDS Phase 3
clinical trial visit www.clinicaltrials.gov.
Multiple Sclerosis: a chronic disease that attacks the
central nervous system
Multiple sclerosis is a chronic
neurodegenerative disease in which a person's immune system causes
damage to the brain and spinal cord. It is an unpredictable disease
that affects 2.8 million people around the world, and the latest
prevalence statistics across 47 countries estimate that at least
30,000 of those affected are children and teenagers.1,2
About Aubagio®
(teriflunomide)
Aubagio is approved in more than 80 countries to
treat certain patients with relapsing-remitting multiple sclerosis,
with additional marketing applications under review by regulatory
authorities globally. Aubagio is supported by one of the largest
clinical programs of any MS therapy, with more than 5,000 trial
participants in 36 countries, as well as a Phase 4 study program
with more than 3,600 patients currently enrolled. There is over 16
years of combined clinical and real-world experience with Aubagio.
More than 110,000 patients are currently being treated with Aubagio
commercially worldwide.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. |
Media Relations ContactSally Bain Tel.: +1 (781)
264-1091Sally.Bain@sanofi.com |
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1 Walton, C., King, R., Rechtman, L., Kaye, W., Leray, E.,
Marrie, R., Robertson, N., La Rocca, N., Uitdehaag, B., van der
Mei, I., Wallin, M., Helme, A., Angood Napier, C., Rijke, N., &
Baneke, P. Rising prevalence of multiple sclerosis worldwide:
Insights from the Atlas of MS, third edition. Multiple Sclerosis
Journal 2020; 26:14.
2 The Multiple Sclerosis International Federation Atlas of MS,
3rd ed, September 2020. https://www.atlasofms.org.
3 Renoux C, Vukusic S, Confavreux C. The natural history of
multiple sclerosis with childhood onset. Clin Neurol Neurosurg.
2008;110(9):897-904.
4 Alroughani R, Boyko A. Pediatric multiple sclerosis: a review.
BMC Neurol 2018; 18:27.
5 Pena JA, Lotze TE. Pediatric multiple sclerosis: current
concepts and consensus definitions. Autoimmune Diseases
2013(3):673947.
6 MacAllister WS, Boyd JR, Holland NJ, Milazzo MC, Krupp LB. The
psychosocial consequences of pediatric multiple sclerosis.
Neurology. 2007;68(16 SUPPL. 2):S66–S69.
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