Sanofi

Note: This story was updated Sept. 23, 2025, to correct the generic name of Aubagio from tolebrutinib to teriflunomide. The U.S. Food and Drug Administration (FDA) has delayed by three months its decision on whether or not to approve Sanofi’s tolebrutinib as a treatment for multiple sclerosis (MS),…

Frexalimab, an experimental antibody-based medication, was well tolerated and maintained disease control over two years in adults with relapsing forms of multiple sclerosis (MS). That’s according to new data from an open-label extension to a Phase 2 clinical trial (NCT04879628) in which frexalimab outperformed a placebo at reducing…

Bolstered by Phase 2 trial data showing that frexalimab safely reduces the number of brain lesions in people with relapsing forms of multiple sclerosis (MS), developer Sanofi has launched a pair of Phase 3 studies that will test the investigational therapy in relapsing and progressive MS. One of…

The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on Phase 3 trials testing the investigational therapy tolebrutinib in people with multiple sclerosis (MS) and myasthenia gravis based on reports of medication-induced liver injury. Under the clinical hold, new enrollment at U.S. sites…

#ACTRIMS2022 – Cognitive Training Paired With tDCS Aids Patients A treatment to clear “cog fog” would be welcomed by many people with MS. Over 75% of us are troubled by cognitive problems. In this study, adding painless transcranial direct current stimulation to standard cognitive training improved results when compared…

Tolebrutinib, an investigative inhibitor of Bruton’s tyrosine kinase (BTK) being developed by Sanofi to treat all forms of multiple sclerosis (MS), shows the potential to be more potent than other BTK inhibitors also in advanced clinical trials, scientists reported. The findings, based on preclinical data, were shared at the Americas…

Aubagio (teriflunomide) failed to significantly reduce relapses in children with multiple sclerosis (MS), but two years of treatment decreased the number of brain lesions on MRI scans, according to the final results of the Phase 3 TERIKIDS clinical trial. Importantly, the lack of a signficantly lower relapse rate…

Sanofi Genzyme has extended its collaboration with Koneksa to bring digital measures into its Phase 3 trials of tolebrutinib, an investigational therapy for relapsing and progressive forms of multiple sclerosis (MS). Through this joint effort, Koneksa’s digital biomarkers were applied to clinical trials of Parkinson’s…

The U.S. Food and Drug Administration (FDA) has rejected an application requesting the expansion of Aubagio (teriflunomide) for the treatment of children and adolescents, ages 10 to 17, with relapsing forms of multiple sclerosis (MS). “The FDA deemed the data submitted were not sufficient to obtain approval of…

Treatment with Zeposia (ozanimod) significantly reduces the risk of relapse, decreases the proportion of patients experiencing a relapse, and has a better safety profile than Aubagio (teriflunomide) for people with relapsing multiple sclerosis (MS), according to an indirect comparison of clinical trial data.

Two global Phase 3 clinical trials, both comparing Sanofi Genzyme’s investigational tolebrutinib with its approved therapy Aubagio, are enrolling a total of 1,800 people with relapsing multiple sclerosis (MS), the company said. All patients in both studies — dubbed GEMINI 1 and GEMINI 2 — will…

Review Study Examines Factors That Affect MS Patients’ Quality of Life What affects the qualify of your life as someone who lives with MS? Fatigue is at the top of my list, followed by difficulty walking. Now, COVID-19 plus gray, winter weather have added a bit of depression. So,…

Janssen Pharmaceuticals’ investigational oral therapy ponesimod is superior to Sanofi’s Aubagio (teriflunomide) in delaying disability progression in adults with relapsing multiple sclerosis (MS), according to exploratory analyses of OPTIMUM clinical trial data. These and other findings from Janssen’s MS research program, including on the health…

In a $3.68 billion transaction, Sanofi is preparing to acquire Principia Biopharma, a biopharmaceutical company focused on the development of therapies for disorders caused by dysregulation of the immune system, including multiple sclerosis (MS). The decision was unanimously approved by the board of directors of…

A first person has enrolled in Sanofi’s Phase 3 trial evaluating SAR442168, an oral BTK inhibitor intended to treat relapsing forms of multiple sclerosis (MS), Sanofi’s partner, Principia Biopharma, announced. “We are delighted that Sanofi has initiated … [this] trial in patients with relapsing MS,” Roy Hardiman, chief…

Five people with multiple sclerosis (MS) who tested positive for COVID-19 while being treated with Aubagio (teriflunomide)  all developed a mild infection, had good outcomes, and experienced no disease relapses, a case study reported. These findings suggest that use of Aubagio, a disease-modifying therapy that acts on the immune system,…

New Nanosensor May Help to Diagnose MS at Early Stages My neurologist likes to say that “brain is time.” The sooner MS is treated the more time you can buy before the brain begins to deteriorate and MS symptoms appear. Being able to diagnose MS sooner means earlier treatment.

The investigational, oral BTK inhibitor SAR442168 can limit the number of new inflammatory brain lesions in people with relapsing forms of multiple sclerosis (MS), results from a Phase 2b clinical trial show. “The results of this study give hope that SAR442168 may become an important…

Sanofi will host an online science session to present results of a Phase 2b clinical trial testing the safety and efficacy of its investigational, oral BTK inhibitor SAR442168 in people with multiple sclerosis (MS). The virtual session, owing to the cancellation of the American Academy…

A new public-private initiative brings academic and industry researchers from 15 European countries together in a large-scale effort to understand differences and commonalities in seven immune-mediated and inflammatory diseases, including multiple sclerosis, so to better predict a patient’s likely response to treatment and likely disease progression. The project, called 3TR…

Sanofi is working with Happify Health to develop an app that addresses the mental health of people with multiple sclerosis (MS) through cognitive behavior therapy. The physical symptoms of MS, such as fatigue and spasticity, are well-documented. But many patients also struggle with bouts of depression,…

The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma, in collaboration with Sanofi Genzyme, for MS and other central nervous…

Aubagio taken as 14 milligram (mg) tablet once daily significantly reduces the risk of relapse in people with relapsing multiple sclerosis (MS) over time irrespective of their prior treatment history, a pooled analysis of Phase 2 and Phase 3 trial results show. The findings were presented at the 2019…

The U.S. Food and Drug Administration (FDA) has approved a generic version of  Aubagio (teriflunomide) tablets at the 7 mg and 14 mg doses marketed by Sanofi, according to the generic’s manufacturer, Glenmark Pharmaceuticals. The FDA’s decision to approve the company’s application for teriflunomide tablets at two…

Denali Therapeutics and Sanofi will collaborate to develop a compound called DNL747 that may treat multiple sclerosis (MS) and other neurodegenerative disorders. The companies will also jointly work on the development of a separate possible therapy, DNL758, for systemic inflammatory diseases such as rheumatoid arthritis and psoriasis. Both DNL747 and DNL758…

Many of us have received help to pay for our MS medications. Now there’s a chance that assistance could be threatened. A recent article in the The Wall Street Journal reports that U.S. government prosecutors are looking into whether some pharmaceutical companies’ patient assistance programs are on the wrong…

Hair thinning in relapsing-remitting multiple sclerosis (RRMS) patients using Aubagio is usually mild and temporary, and does not require stopping treatment, a small real-world study reports. The research, “Real-World Observational Evaluation of Hair Thinning in Patients with Multiple Sclerosis Receiving Teriflunomide: Is It an Issue in Clinical…

Results from a first-in-human study assessing the safety and early activity of PRN2246 confirmed that the oral compound can reach into the brain and spinal cord. This finding adds new evidence that PRN2246 has the potential to target the immune cells that drive the inflammatory process involved in multiple sclerosis…

The U.K.’s National Health Service (NHS) turned 70 last week. In England, yes, we are mourning our semi-final defeat by Croatia in the World Cup, but to most of us, the NHS is the U.K.’s crowning glory. There are innumerable problems and proposed solutions involving the institution, yet…

I’m agonizing over an important decision and it’s driving me crazy. I’m usually a quick decision-maker, but this one is tough. I have my analytical hat on, trying to look at my choices from a scientific standpoint. Unfortunately, my anxiety kicks in, and my hat…