Activity Forums General General Discussions Janssen Submits New Drug for FDA Approval

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    Janssen, a division of Johnson & Johnson, has submitted an application to the U.S. Food and Drug Administration (FDA) asking for approval of a new oral medication, Ponesimod, for relapsing form of Multiple Sclerosis (MS).

    Ponesimod, formerly ACT-128800, is an experimental treatment that targets the protein sphingosine-1-phosphate receptor 1 (S1P1) with reportedly high selectivity. Ponesimod works by trapping immune cells in the lymph nodes thus preventing damage to the nervous system.

    The New Drug Application submitted to the FDA is based on data from the pivotal Phase 3 OPTIMUM clinical trial, NCT02425644. This trial compared the efficacy and safety of ponesimod to Aubagio (teriflunomide), a Sanofi medication approved as first-line therapy for MS.

    Even though they use different methods, Aubagio and penosimod both work with by reducing the activity of the immune system.

    The OPTIMUM study enrolled 1,133 people with relapsing-remitting MS (RRMS) or active secondary progressive MS (SPMS). The participants were randomly assigned to receive either 20 mg of ponesimod or 14 mg of Aubagio. Both medications were taken by mouth once a day for just over two years.

    When comparing ponesimod and Aubagio, the ponesimod showed a 30.5% decrease in the average annualized relapse rate (ARR). Ponesimod showed 0.202 relapses per year where Aubagio showed 0.290 ARR.

    Ponesimod also showed a significant reduction in the average of new lesions. When compared to Aubagio pomesimod showed a 56% reduction of new lesions visible on magnetic resonance imaging (MRI). A trend towards less disability progression but while mentioned, it did not become statistically significant.

    One thing that it is important to note is there was a significant reduction in fatigue with ponesimod when compared to Aubagio. It should be noted that a new scale was used for assessing fatigue. The Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis, or FSIQ-RMS.

    “Fatigue is one of the most common and debilitating symptoms of MS and yet, it’s one of the most challenging to manage and treat,” Husseini Manji, MD, the global therapeutic area head for neuroscience at Janssen Research & Development, part of Johnson & Johnson, said in a press release.

    “We were thrilled to see improvement in fatigue-related symptoms as part of the Phase 3 OPTIMUM trial as we know the profound impact it may have on a person’s daily life. The improvement in fatigue, coupled with reduction in ARR, demonstrate great promise for ponesimod with patients seeking a more targeted treatment option,” Manji said.

    Janssen recently submitted a similar application for ponesimod to the European Medicines Agency (EMA), seeking the therapy’s approval in the EU.


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