Janssen Asks EMA to Approve Oral Ponesimod to Treat Relapsing MS

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by Marisa Wexler MS |

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Zeposia before EMA

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 1 (S1P1), and reportedly with high selectivity. In doing so, it works to ‘trap’ immune cells in lymph nodes, limiting the damage they can do to the nervous system.

The MS therapies Gilenya (fingolimod) and Mayzent (siponimod), both of which are already approved in Europe, are also S1P1 receptor modulators, working through a similar mechanism of action.

The company’s Marketing Authorisation Application for ponesimod is based on data from the Phase 3 clinical trial OPTIMUM (NCT02425644). In this trial, 1,133 people with relapsing-remitting MS (RRMS) or active secondary progressive MS  (SPMS) were randomly assigned to either ponesimod at 20 mg or Aubagio (teriflunomide) at 14 mg, both taken by mouth once a day for two years (108 weeks).

Aubagio, by Sanofi, is an approved first-line therapy for MS. Like ponesimod, it works by reducing the activity of the immune system, albeit through different mechanisms.

Topline results from OPTIMUM showed that the annualized relapse rate (ARR) was significantly reduced by 30.5% with ponesimod, as compared to Aubagio, treatment — on average, 0.202 relapses per year in the ponesimod group and 0.290 among those given Aubagio.

A significant reduction (56%) in the number of new active, inflammatory brain lesions visible on a magnetic resonance imaging (MRI) scan was also seen with ponesimod treatment, as compared to Aubagio. There was also a trend towards lesser disability progression with ponesimod, but this did not reach statistical significance.

Ponesimod did lead to a statistically significant reduction in reported fatigue relative to Aubagio.

“Fatigue remains a challenging, yet invisible, symptom among those living with MS. We are encouraged by the results ponesimod shows in alleviating this symptom, as well as the reduction in new inflammatory lesions and disability accumulation,” Husseini Manji, MD, FRCPC, the Global Therapeutic Area head for Neuroscience at Janssen Research & Development, said in a press release.

“We look forward to collaborating closely with the EMA as the application process progresses,” Manji added.

Ponesimod’s safety was consistent with the that reported in previous trials, and with the known safety profile of other S1P receptor modulators.

“More than 2.3 million people worldwide live with MS — including 700,000 in Europe alone — and of this population, approximately 85 percent are initially diagnosed with relapsing MS. This submission is an important milestone as we work to bring a new treatment option to those living with relapsing forms of MS,” Mathai Mammen, MD, PhD, the global head of Janssen Research & Development, concluded.

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