Johnson & Johnson's new oral drug for multiple sclerosis, Ponvory, receives UK approval

Recently, the British Medicines and Health Products Administration (MHRA) approved Johnson & Johnson's multiple sclerosis (MS) oral new drug Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis (RMS)
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Specifically: According to the definition of clinical or imaging characteristics, adult patients with RMS with active disease

The approval is based on data from the Phase 3 OPTIMUM trial
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The trial was carried out in 1133 adult patients with RMS in 28 countries and evaluated the efficacy and safety of once-daily oral Ponvory and once-daily oral Aubagio (teriflunomide, teriflunomide)

It is worth mentioning that OPTIMUM is the first study to compare two oral disease correction therapies head-to-head in the treatment of RMS
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The results showed that, in terms of the primary endpoint of annualized recurrence rate (ARR), Ponvory has a better efficacy than Aubagio, reducing ARR statistically by 30.

MS is an immune-mediated chronic central nervous system disease characterized by inflammation, demyelination, and axonal/neuronal destruction, which ultimately leads to severe disability
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There is currently no cure for MS, and there are still significant unmet medical needs in this field

Ponvory is a novel oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, which was approved for marketing in the United States and the European Union in March 2021 and May 2021 for the treatment of adult patients with RMS
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The drug is the fourth marketed drug in the S1P modulator category and the ninth branded oral drug for the treatment of MS

The launch of Ponvory will bring a new oral treatment option to the RMS patient population and help solve some of the lifelong and life-limiting symptoms of MS

Reference source: MHRA nod for Janssen's relapsing multiple sclerosis drug Ponvory