News Janssen Asks EMA to Approve Oral Ponesimod to Treat Relapsing MS Janssen Asks EMA to Approve Oral Ponesimod to Treat Relapsing MS by Marisa Wexler, MS | March 5, 2020 Share this article: Share article via email Copy article link JanssenĀ has submitted an application toĀ the European Medicines Agency (EMA) asking that ponesimodĀ 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 theĀ 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 GilenyaĀ (fingolimod) andĀ MayzentĀ (siponimod), both of which are already approved in Europe, are also S1P1 receptor modulators, working through a similar mechanism of action. The company’sĀ Marketing Authorisation ApplicationĀ for ponesimod is based on data from the Phase 3 clinical trial OPTIMUM (NCT02425644). In this trial, 1,133 people withĀ relapsing-remitting MS (RRMS) or activeĀ secondary progressive MS Ā (SPMS) were randomly assigned to either ponesimod at 20 mgĀ orĀ 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 ā 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 thisĀ symptom, as well as the reduction in new inflammatory lesions and disability accumulation,” Husseini Manji, MD, FRCPC, the Global Therapeutic AreaĀ head for Neuroscience at Janssen Research & Development,Ā said in aĀ press release. “We look forward to collaborating closely with the EMA as the application process progresses,” Manji added. Ponesimodās 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 ā including 700,000 inĀ Europe alone ā and of this population, approximately 85 percent are initiallyĀ diagnosed with relapsing MS.Ā 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,Ā MD, PhD, the global head of Janssen Research & Development, concluded. Print This Page About the Author Marisa Wexler, MS Marisa holds a Master of Science in cellular and molecular pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. Her areas of expertise include cancer biology, immunology, and genetics, and she has worked as a science writing and communications intern for the Genetics Society of America. Tags EMA, Gilenya (fingolimod), Janssen, Mayzent (siponimod), OPTIMUM, Ponesimod
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