Ponvory ™ (Ponesimod; Janssen) is now available for the treatment of adults with relapsed forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
Ponvory is an oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator administered once daily. The approval was based on results from a phase 3 randomized head-to-head study (ClinicalTrials.gov: NCT02425644) comparing the efficacy and safety of Ponvory with teriflunomide in 1,133 patients with relapsing MS.
Study results showed that treatment with Ponvory resulted in a statistically significant reduction in the annualized relapse rate (primary endpoint) compared to teriflunomide. In addition, Ponvory demonstrated superiority in reducing the number of new gadolinium-enhancing T1 and T2 lesions compared to teriflunomide.
In terms of safety, the overall incidence of adverse reactions was similar between Ponvory and teriflunomide. The most common side effects (incidence of at least 10%) in patients treated with Ponvory were upper respiratory tract infections, increases in liver transaminase, and high blood pressure.
Before starting Ponvory treatment, healthcare providers should have an up-to-date complete blood count, electrocardiogram, and transaminase and bilirubin levels. Starting treatment leads to a decrease in heart rate. Therefore, monitoring of the first dose is recommended in patients with certain pre-existing heart conditions (e.g. first or second degree bradycardia) [Mobitz type I] history of atrioventricular (AV) block, myocardial infarction, or heart failure).
Ponvory is available as 2, 3, 4, 5, 6, 7, 8, 9 and 10 mg film-coated tablets in a pack of 14 and as a 20 mg in a pack of 30 maintenance dose bottles.
Ponvory ™ [package insert]. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2021.
This article originally appeared on MPR