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news.Johnson & Johnson’s Janssen Pharmaceutical Companies have announced the US Food and Drug Administration (FDA) approval of PONVORY for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system, where the protective casing that insulates nerve cells, called myelin, is damaged or destroyed by immune cells. Credit: Matteo Badini/Unsplash.
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Johnson & Johnson’s Janssen Pharmaceutical Companies have announced the US Food and Drug Administration (FDA) approval of PONVORY for the treatment of relapsing forms of multiple sclerosis (MS) in adults.
Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system, where the protective casing that insulates nerve cells, called myelin, is damaged or destroyed by immune cells causing inflammation.
Backed by more than 10 years of clinical research, PONVORY (or ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, offers MS patients better results in reducing the yearly relapse rates and a proven safety profile, when compared to other established therapies.
The USFDA based its approval on a two-year, head-to-head Phase 3 clinical trial between PONVORY 20 mg and teriflunomide (Aubagio) 14 mg, where PONVORY reduced annual relapses by 30.5% when compared to Aubagio, demonstrating remarkable superior efficacy. In addition, PONVORY prevented deterioration of the disability in most patients.
National MS Society executive vice-president of Research Bruce Bebo said: “MS is a complex disease, and any individual’s response to MS disease-modifying therapy can vary. It’s so important that people living with MS have access to effective treatment options. We are pleased that there is a new therapy approved for relapsing MS.”
Provided stoppage of treatment is required, PONVORY exits the blood system inside of a week, while the effects on the immune system also wear off within a couple of weeks for most patients.
No genetic testing or first-dose monitoring is required and PONVORY has no known food restrictions.
Cleveland Clinic Neurological Institute vice-chair for Research and Mellen Center for MS Treatment and Research staff neurologist Robert J. Fox explained: “In the pivotal study, ponesimod demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared against teriflunomide, another oral MS therapy. Those results, combined with a favourable side effect profile, make ponesimod a useful treatment option for people with relapsing MS.”
As a member of the ponesimod Advisory Board, Fox was a paid consultant to Actelion Pharmaceuticals Ltd and Janssen.
Johnson & Johnson, Janssen Research & Development, Global Head Mathai Mammen stated: “Every person with multiple sclerosis is affected differently, given variability in both the underlying disease and emerging symptoms. Continued innovation in this space is critical, and we’re committed to meeting patients’ evolving healthcare needs. We are proud to offer PONVORY as a valuable new option for people with MS that may help them gain better control of their disease.”
Janssen also presented a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q1 2020 for ponesimod, for the treatment of relapsing MS in adults. The submission is currently under review.