Ponesimod

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:…

Note: This story was updated Jan. 12, 2022, to note that Ponvory is approved in the U.K. for people with relapsing forms of MS who have active disease, defined by clinical or imaging features. The National Institute for Health and Care Excellence (NICE) has recommended that Ponvory (ponesimod)…

The Scottish Medicines Consortium (SMC) has recommended that Ponvory (ponesimod) be offered through the National Health Service (NHS) Scotland to people with active, relapsing forms of multiple sclerosis (MS). The decision means that the oral therapy will be available at low or no cost to patients with clinically isolated syndrome (CIS),…

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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…

The European Commission has approved Ponvory (ponesimod) to treat adults with relapsing forms of multiple sclerosis (MS) and active disease, as defined by clinical or imaging features. The approval, which follows a recommendation from the Committee for Medicinal Products for Human Use in March, covers clinically isolated…

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…

Among oral sphingosine-1-phosphate (S1P) receptor modulators for multiple sclerosis (MS), Novartis’s Gilenya (fingolimod) remains physicians’ favorite in the U.S., but prescriptions of recently-launched Bristol Myers Squibb’s Zeposia (ozanimod) are beginning to rise, according to a survey conducted by Spherix Global Insights. Also, COVID-19 not…

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…

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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…

Actelion‘s ponesimod, an investigational oral treatment, is superior to Sanofi‘s Aubagio (teriflunomide) in lessening the frequency of relapses and easing fatigue symptoms in adults with active, relapsing multiple sclerosis (MS), results of the OPTIMUM trial show. These data will lay the ground for submissions…

3D Imaging of Brain Lesions May Spot Those Most Likely to Heal, Guiding Treatment These scientists are working to create a new diagnostic tool that would allow doctors to use an MRI to look at brain lesions in 3D. This would allow them to see the shape and surface…

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…

Actelion is recruiting about 600 relapsing multiple sclerosis (MS) patients to a Phase 3 trial testing the addition of oral ponesimod to Tecfidera (dimethyl fumarate) in people who continue experiencing relapses while on the treatment. Ponesimod works in a similar way to Novartis’ Gilenya (fingolimod) — making immune…

Actelion announced that it will investigate the therapeutic potential of a new, oral combination therapy with ponesimod and Tecfidera (dimethyl fumarate) as a treatment for relapsing multiple sclerosis (RMS). The Phase 3 clinical study, being conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA), aims to find…