Janssen sends off NDA for new multiple sclerosis drug ponesimod

Aubagio
Johnson & Johnson's ponesimod recently beat blockbuster multiple sclerosis treatment Aubagio in a head-to-head test, and it's now hoping for an FDA approval. (Sanofi)

Johnson & Johnson has handed in its New Drug Application for its multiple sclerosis (MS) hopeful as it hopes to get in on this blockbuster market.

The therapy, ponesimod, is an S1P1 immunomodulator and has come through testing with flying colors over the past year. Last fall, J&J showed that its med could, in a head-to-head study, beat out Sanofi’s Aubagio at reducing flare-ups that worsen MS patients' symptoms. It’s these data the Big Pharma is taking to the FDA.

Ponesimod was one of two late-stage programs J&J picked up in its $30 billion buyout of Actelion back in 2017. Aubagio made Sanofi €1.8 billion last year, a rise of 10% on the year-before period, and is one of its biggest-selling meds. J&J will hope, if it can gain approval, to grab a share of that market.

Last September, J&J released detailed data that showed its drug hit the primary endpoint of lowering patients' annualized relapse rate, or the average number of relapses a person faces a year. The rate for ponesimod patients was 0.202 relapses per year versus 0.290 for the Aubagio group, an improvement of 31%.

The study, presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis, tested a 20-mg dose of ponesimod against the labeled 14-mg dose of Aubagio (teriflunomide) in adults with the relapsing form of MS over two years.

The drug also outdid Aubagio at reducing fatigue as measured by The Fatigue Symptoms and Impacts Questionnaire–Relapsing Multiple Sclerosis, a patient-reported questionnaire designed to assess fatigue-related symptoms and how they affect people with MS. The investigators looked at results for a prespecified time point and found that the fatigue of ponesimod patients stabilized, while that of the Aubagio patients worsened over time.

Ponesimod was a rising star when Actelion began the phase 3 trial in 2015, but while it showed it can beat out Aubagio, it now faces competition from Roche’s MS therapy Ocrevus (ocrelizumab). Indirect analyses suggest Ocrevus is better than Aubagio at reducing relapses.

Mathai Mammen, M.D., Ph.D., global head of Janssen R&D: said: “In the coming months, we'll work closely with the FDA to bring ponesimod one step closer to the MS patient community and remain encouraged by its superior efficacy profile—specifically in reducing new inflammatory lesions and disability accumulation—in comparison to a leading therapy on the market.”

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