Media Update: New two-year efficacy and safety data for tolebrutinib, Sanofi’s investigational, brain-penetrant and bioactive BTK inhibitor, to be presented at ECTRIMS 2022

October 26, 2022
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New two-year efficacy and safety data for tolebrutinib, Sanofi’s investigational, brain-penetrant and bioactive BTK inhibitor, to be presented at ECTRIMS 2022

Paris, October 26, 2022. New data will be presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from the long-term Phase 2b extension trial assessing two-year safety and efficacy of tolebrutinib, Sanofi’s investigational, brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor, in patients with relapsing forms of MS, including those with highly active disease. Sanofi will also highlight findings from a large-scale proteomic analysis that provides mechanistic validation of tolebrutinib and new insight into protein alterations in MS patients, which may ultimately inform new biomarkers of disease progression to evaluate therapeutic efficacy.

Also to be presented at the congress are studies reinforcing the clinical profiles of approved MS therapies AUBAGIO® (teriflunomide) and LEMTRADA ® (alemtuzumab).

Abstracts accepted for presentation at ECTRIMS include:







Evaluating Large Scale Proteomic Changes in Cerebrospinal Fluid of Multiple Sclerosis PatientsePoster: #EP1037
Oct. 26, 08:00 CEST

Exploring the Utility of ActiGraph in Measuring Gait Impairment and Physical Activity in Patients with MS Using Digital BiomarkersePoster: #EP0885
Oct. 26, 08:00 CEST

MRI, Efficacy, and Safety of Tolebrutinib in Patients with Highly Active Disease (HAD): 2-Year Data from the Phase 2b Long-term Safety (LTS) StudyPoster: #P292
Oct. 26, 16:30 CEST

Safety and Clinical Efficacy Outcomes from the Long-term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis: 2-Year ResultsPoster: #P308
Oct. 26, 16:30 CEST

MRI Outcomes from the Long-term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis: 2-Year ResultsPoster: #P297
Oct. 26, 16:30 CEST

Lack of Rebound Disease Activity in Patients with Relapsing Multiple Sclerosis Following Placebo Run-out in the Tolebrutinib Phase 2b TrialPoster: #P296
Oct. 26, 16:30 CEST

Evaluating the Effect of a Bruton’s Tyrosine Kinase Inhibitor in a Murine Experimental Autoimmune Encephalomyelitis Model of Multiple SclerosisPoster: #P174
Oct. 26, 16:30 CEST




Real-world Outcomes of Teriflunomide in Relapsing-Remitting Multiple Sclerosis: A Prospective Cohort StudyePoster: #EP1126
Oct. 26, 8:00 CEST
Teriflunomide Routine Clinical Practice in Patients with Relapsing-Remitting Multiple Sclerosis: Final Results of the TAURUS MS II StudyPoster: #P374
Oct. 26, 16:30 CEST

Long-term Safety of Teriflunomide in Multiple Sclerosis Patients: Results of Prospective Comparative Studies in Three European CountriesPoster: #P738
Oct. 27, 17:00 CEST

COVID-19 Severity and Vaccination Effect in Persons with MS Treated with AlemtuzumabPoster: #P149
Oct. 26, 16:30 CEST

FranchiseShort-term Change in Disability and Processing Speed, but Not Relapse Rate, Predicts Health Related Quality of Life Five and Ten Years LaterScientific Session #11: Quality of Life - 0104
Oct. 27, 15:35 – 15:42 CEST


About tolebrutinib
Tolebrutinib is an investigational brain-penetrant and bioactive Bruton’s tyrosine kinase (BTK) inhibitor that achieves CSF concentrations predicted to modulate B lymphocytes and microglial cells. Tolebrutinib is being evaluated in Phase 3 clinical trials for the treatment of relapsing forms of MS (RMS), non-relapsing secondary progressive MS (nrSPMS), primary progressive MS (PPMS), and myasthenia gravis (MG) and its safety and efficacy have not been evaluated by any regulatory authority worldwide. For more information on tolebrutinib clinical trials, please visit

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 17 years of combined clinical and real-world experience with Aubagio. More than 114,000 patients are currently being treated with Aubagio commercially worldwide.

About Lemtrada® (alemtuzumab)

Lemtrada is approved in more than 71 countries, with additional marketing applications under review by regulatory authorities globally. Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients worldwide and >11,000 patient-years of follow-up. More than 27,000 patients have been treated with Lemtrada commercially worldwide.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

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