Ponvory™ (ponesimod; Janssen) is now available for the treatment of adults with relapsing forms of multiple sclerosis (MS), including 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. The approval was based on results from a head-to-head, randomized, phase 3 trial (ClinicalTrials.gov: NCT02425644), which compared the efficacy and safety of Ponvory to teriflunomide in 1133 patients with relapsing MS.
Study findings showed that treatment with Ponvory resulted in a statistically significant reduction in the annualized relapse rate (primary endpoint) when compared with teriflunomide. Moreover, Ponvory showed superiority in reducing the number of new gadolinium-enhancing T1 and T2 lesions compared with teriflunomide.
As for safety, the overall incidence of adverse reactions was similar between Ponvory and teriflunomide. The most common adverse reactions (incidence of at least 10%) in Ponvory-treated patients were upper respiratory infection, hepatic transaminase elevation, and hypertension.
Prior to starting treatment with Ponvory, healthcare providers should obtain a recent complete blood count, electrocardiogram, and transaminase and bilirubin levels. 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 (eg, bradycardia, first- or second-degree [Mobitz type I] atrioventricular (AV) block, history of myocardial infarction or heart failure).
Ponvory is 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.
Ponvory™ [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2021.