Ponvory is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that keeps lymphocytes out of the blood
US FDA approves Janssen’s Ponvory. (Credit: Michal Jarmoluk from Pixabay.)
Janssen, the pharmaceutical subsidiary of Johnson & Johnson, has secured the US Food and Drug Administration (FDA) approval for Ponvory (ponesimod) to treat a type of relapsing multiple sclerosis (MS).
The FDA approval includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.
Ponvory is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that traps lymphocytes in the lymph nodes, keeping them out of the blood.
The drug reduces annualised relapse rates in MS patients, compared to established oral therapy, with a safety profile backed by more than a decade long clinical research, said the company.
Janssen research and development global head Mathai Mammen said: “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.”
The US FDA approval of Ponvory is partially supported by Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis (OPTIMUM) trial.
OPTIMUM is a two-year, head-to-head Phase 3 clinical trial that evaluated Ponvory 20mg compared to teriflunomide (Aubagio) 14mg in patients with relapsing MS.
In the study, Ponvory showed superior efficacy in significantly reducing annual relapses, compared to teriflunomide arm.
The company said that 71% of patients treated with Ponvory reported no confirmed relapses, compared to 61% in the teriflunomide group.
Also, Ponvory showed superiority in reducing the number of new gadolinium-enhancing (GdE) T1 lesions by 59% and the number of new or enlarging T2 lesions by 56%, compared to teriflunomide.
Janssen ponesimod advisory board member Robert Fox said: “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.”
In 2017, Actelion Pharmaceuticals, a member of Janssen, has reached a revenue-sharing agreement with Idorsia Pharmaceuticals, based on sales of ponesimod.