The Food and Drug Administration (FDA) has approved Ponvory™ (ponesimod; Janssen) for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

Ponesimod is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator. The approval was based on results from a phase 3 head-to-head, randomized trial of ponesimod vs teriflunomide. A total of 1133 patients with relapsing MS, were randomly assigned to either ponesimod 20mg once daily or teriflunomide 14mg once daily.

Results showed that the annualized relapse rate from baseline to Week 108 was reduced by 30.5% for the ponesimod group vs the teriflunomoide group, meeting the trial’s primary endpoint. The Company stated that 71% of patients treated with ponesimod had no confirmed relapses, compared to 61% in the teriflunomide group.

Moreover, ponesimod showed superiority in reducing the number of new gadolinium-enhancing (GdE) T1 and T2 lesions compared with  teriflunomide by 59% and 56%, respectively.

As for adverse events, overall rates were similar to teriflunomide. The most common adverse events observed in the phase 3 trial in ponesimod-treated patients were upper respiratory infection, hepatic transaminase elevation, and hypertension.

Initiation of the treatment results in a decrease in heart rate, and as such first-dose monitoring is recommended in patients with certain preexisting cardiac conditions. Ponvory will be available as 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10mg film-coated tablets in a 14-count starter pack, and as 20mg in a 30-count maintenance dose bottle.

Dr Bruce Bebo, Executive Vice President of Research at the National MS Society said, “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.”

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  1. Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions. [press release]. Titusville, NJ: Janssen; March 19, 2021.
  2. Ponvory™ [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2021.