Janssen

Treatment with Ponvory (ponesimod) significantly reduces the risk of worsening disability or new relapses for people with relapsing forms of multiple sclerosis (MS) compared with a placebo, according to a new analysis funded by the therapy’s maker Janssen. The study, “Comparative Efficacy of Relapsing Multiple Sclerosis Therapies:…

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The National Institute for Health and Care Excellence (NICE) will not recommend that Ponvory (ponesimod) be added to the National Health Service (NHS) of England and Wales for people with active, relapsing forms of multiple sclerosis (MS). The provisional decision, made because Ponvory was not found to be…

In the OPTIMUM clinical trial, Ponvory (ponesimod) significantly outperformed Aubagio (teriflunomide) in reducing relapse rates, fatigue, and evidence of brain damage among people with relapsing multiple sclerosis (MS). Based on these results, Ponvory has now been approved in the U.S. and the European Union as a treatment…

A branch of the European Medicines Agency has recommended that Ponvory (ponesimod) be approved to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. This positive opinion from agency’s Committee for Medicinal Products for Human Use (CHMP) covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary…

The U.S. Food and Drug Administration (FDA) has approved Ponvory (ponesimod) as an oral treatment for adults with relapsing forms of multiple sclerosis (MS). The approval covers clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). The treatment is taken as a…

Fatigue is the most impactful symptom on daily functioning in people with relapsing forms of multiple sclerosis (MS) and is more severe in patients with relapse, pain, depression, and sleep disorders, according to a U.S.-based survey. The results were based mostly on a new MS-specific tool called the Fatigue Symptoms…

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…

Janssen has submitted an application to the U.S. Food and Drug Administration (FDA) asking for ponesimod to be approved as an oral treatment for adults with relapsing multiple sclerosis (MS). Ponesimod, formerly ACT-128800, is an experimental treatment that targets the protein sphingosine-1-phosphate…

Ponesimod may soon be a new oral therapy for people with relapsing multiple sclerosis (MS) in Europe, and a filing for its approval in the U.S. is likely within weeks. Janssen Pharmaceuticals, its developer, submitted an application to the European Medicines Agency (EMA) in early March, a first ponesimod filing…

Janssen has submitted an application to the European Medicines Agency (EMA) asking that ponesimod be approved as an oral treatment for adults with relapsing multiple sclerosis (MS) in the European Union. Ponesimod (formerly ACT-128800) is an experimental treatment that targets the sphingosine-1-phosphate receptor…

Janssen has announced positive, top-line results from its Phase 3 OPTIMUM study, testing the effectiveness and safety of ponesimod tablets, compared to Sanofi‘s Aubagio (teriflunomide), in adults with relapsing forms of multiple sclerosis (MS). The study met its primary goal — a reduction in the…