US FDA approves Janssen’s PONVORY for relapsing multiple sclerosis

The US Food and Drug Administration (FDA) has approved the Janssen Pharmaceutical Companies of Johnson & Johnson’s (JNJ) PONVORY (ponesimod) for treating adults with relapsing forms of multiple sclerosis (MS).

PONVORY is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator.

The approval will also include treatment for the clinically isolated syndrome (CIS), relapsing-remitting and active secondary progressive disease (SPMS).

The latest development is partly based on a two-year, head-to-head Phase III trial in which PONVORY 20mg showed superior efficacy in significantly lowering annual relapses by 30.5% compared to teriflunomide (Aubagio) 14mg in patients with relapsing MS.

In addition, nine in ten PONVORY-treated subjects did not exhibit deterioration of the three-month disability and the treatment demonstrated a numerical benefit in delaying disability progression.

JNJ Janssen research and development (R&D) global head Mathai Mammen said: “Every person with multiple sclerosis is affected differently given the variability in both the underlying disease and emerging symptoms.”

In multiple clinical studies over ten years, PONVORY has shown a proven safety profile and was generally well-tolerated.

Furthermore, if PONVORY treatment is stopped, it leaves the blood within a week, with effects on the immune system waning in one to two weeks in the majority of patients. This could provide further flexibility in managing the treatment.

The European Medicines Agency (EMA) is currently reviewing Janssen’s marketing authorization application (MAA) for ponesimod to treat adults with relapsing MS.