General Information

Ponvory (ponesimod) is a sphingosine 1-phosphate receptor modulator.

Ponvory is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Ponvory is supplied as a tablet for oral administration.

Before initiation of treatment with Ponvory, assess the following:

Complete Blood Count

Cardiac Evaluation

Liver Function Tests

Ophthalmic Evaluation

Current or Prior Medications with Immune System Effects

Vaccinations

Titration is required for treatment initiation. After dose titration is complete (see drug label for titration specifics), the recommended maintenance dosage of Ponvory is 20 mg taken orally once daily starting on Day 15. Administer Ponvory orally once daily. Swallow the tablet whole. Ponvory can be taken with or without food.

Mechanism of Action

Ponvory (ponesimod) is a sphingosine 1-phosphate (S1P) receptor 1 modulator that binds with high affinity to S1P receptor 1. Ponesimod blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ponesimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system.

Clinical Trial Results

The FDA approval of Ponvory was based on the OPTIMUM (Oral Ponesimod Versus Teriflunomide In Relapsing Multiple Sclerosis) trial, a head-to-head, prospective, multicenter, randomized, double-blind Phase 3 study comparing efficacy, safety and tolerability of Ponvory 20 mg versus teriflunomide (Aubagio) 14 mg in adults with relapsing MS. The primary endpoint of the study, which included 1,133 participants, was the annualized relapse rate (ARR) from baseline through the study period. Ponvory 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide 14 mg in patients with relapsing MS. Over the study period, 71% of patients treated with Ponvory had no confirmed relapses, compared to 61% in the teriflunomide group. Ponvory was also superior to teriflunomide in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively.