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Sanofi's (SNY) Aubagio Gets EU Nod for MS in Pediatric Patients
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Sanofi (SNY - Free Report) announced that the European Commission has approved Aubagio (teriflunomide) for the treatment of relapsing-remitting multiple sclerosis (“RRMS”) in pediatric patients aged 10 to 17 years.
Following the nod, Aubagio became the first oral multiple sclerosis (“MS”) therapy to be approved in Europe for the first-line treatment of children and adolescents with MS.
The EC approval was based on data from the double-blind, placebo-controlled phase III TERIKIDS study which evaluated Aubagio in 166 pediatric patients with RRMS. Notably, Aubagio was generally well tolerated and had a manageable safety profile in the pediatric population, with no death being reported in the study.
Shares of Sanofi have rallied 8.8% so far this year compared with the industry’s growth of 7.1%.
Image Source: Zacks Investment Research
We note that, earlier this month, the FDA issued a complete response letter to Sanofi’s supplemental new drug application seeking approval of Aubagio for children and adolescents aged 10 to 17 years with relapsing forms of MS.
The FDA believes that the data submitted by Sanofi is not sufficient to grant approval to Aubagio for pediatric patients.
Aubagio is already approved in the United States, Europe and several other countries for the treatment of adult patients with RRMS. The drug generated sales worth €500 million in the first quarter of 2021, reflecting a decrease of 1.1% year over year. Label expansion of Aubagio should boost its sales in the days ahead.
However, competition in the MS segment is intensifying as several companies are developing their candidates or commercializing drugs targeting relapsing MS. Among the newer drugs, in March 2021, the FDA approved Johnson & Johnson’s (JNJ - Free Report) Ponvory (ponesimod) as an oral treatment for relapsing forms of multiple sclerosis (“RMS”). Last month, the EC approved Ponvory as an oral treatment for RMS.
This apart, in March 2020, the FDA approved Bristol Myers Squibb’s (BMY - Free Report) Zeposia (ozanimod) as an oral treatment for RMS. Zeposia is also approved in Europe. Novartis’ (NVS - Free Report) Kesimpta (ofatumumab) was approved by the FDA in August 2020 as a self-administered, targeted B-cell therapy for patients with RMS. Kesimpta is also approved in Europe for the same indication.
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Image: Bigstock
Sanofi's (SNY) Aubagio Gets EU Nod for MS in Pediatric Patients
Sanofi (SNY - Free Report) announced that the European Commission has approved Aubagio (teriflunomide) for the treatment of relapsing-remitting multiple sclerosis (“RRMS”) in pediatric patients aged 10 to 17 years.
Following the nod, Aubagio became the first oral multiple sclerosis (“MS”) therapy to be approved in Europe for the first-line treatment of children and adolescents with MS.
The EC approval was based on data from the double-blind, placebo-controlled phase III TERIKIDS study which evaluated Aubagio in 166 pediatric patients with RRMS. Notably, Aubagio was generally well tolerated and had a manageable safety profile in the pediatric population, with no death being reported in the study.
Shares of Sanofi have rallied 8.8% so far this year compared with the industry’s growth of 7.1%.
We note that, earlier this month, the FDA issued a complete response letter to Sanofi’s supplemental new drug application seeking approval of Aubagio for children and adolescents aged 10 to 17 years with relapsing forms of MS.
The FDA believes that the data submitted by Sanofi is not sufficient to grant approval to Aubagio for pediatric patients.
Aubagio is already approved in the United States, Europe and several other countries for the treatment of adult patients with RRMS. The drug generated sales worth €500 million in the first quarter of 2021, reflecting a decrease of 1.1% year over year. Label expansion of Aubagio should boost its sales in the days ahead.
However, competition in the MS segment is intensifying as several companies are developing their candidates or commercializing drugs targeting relapsing MS. Among the newer drugs, in March 2021, the FDA approved Johnson & Johnson’s (JNJ - Free Report) Ponvory (ponesimod) as an oral treatment for relapsing forms of multiple sclerosis (“RMS”). Last month, the EC approved Ponvory as an oral treatment for RMS.
This apart, in March 2020, the FDA approved Bristol Myers Squibb’s (BMY - Free Report) Zeposia (ozanimod) as an oral treatment for RMS. Zeposia is also approved in Europe. Novartis’ (NVS - Free Report) Kesimpta (ofatumumab) was approved by the FDA in August 2020 as a self-administered, targeted B-cell therapy for patients with RMS. Kesimpta is also approved in Europe for the same indication.
Zacks Rank
Sanofi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.
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