Ponesimod (Ponvory) for the treatment of adults with relapsing multiple sclerosis (MS).
Nine in 10 patients with multiple sclerosis who received the medication did not have worsening of 3-month disability, and ponesimod showed a numerical benefit in delaying disability progression.
Clinical trials found that it is superior to teriflunomide in reducing annual relapses and brain lesions.
Ponesimod is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator.
It can treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Approval is partially based on a 2-year, head-to-head phase 3 clinical trial: ponesimod demonstrated superior efficacy in significantly reducing annual relapse by 30.5% compared to teriflunomide 14 mg in patients with relapsing MS.
Over the study period, 71% of patients treated with ponesimod had no confirmed relapses, compared to 61% in the teriflunomide group.
It was 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.
It prevents disability from worsening for most people, 9 in 10 patients who received the medication did not have worsening of 3-month disability.
The drug dissipates within 1 week if treatment needs to be stopped and its effects on the immune system wear off in 1 to 2 weeks for most patients.
Ponesimod has a proven safety profile and was generally well-tolerated over multiple clinical studies totaling more than 10 years, with overall adverse event (AE) rates similar to placebo in the phase 2 and teriflunomide in the phase 3 trials.
Most common AEs observed were upper respiratory infection, hepatic transaminase elevation, and hypertension.