FDA Approves Ponvory (ponesimod) For Adults With Relapsing Forms of MS

 FDA APPROVED

     

Ponesimod

Medication

Description

Description

Ponesimod, sold under the brand name Ponvory, is a medication for the treatment of multiple sclerosis. The most common side effects include upper respiratory tract infection, hepatic transaminase elevation, and hypertension. Ponesimod was approved for medical use in the United States in March 2021

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.

Officials with the FDA have granted approval to ponesimod (Ponvory, Janssen) for the treatment of adults with relapsing multiple sclerosis (MS). According to a press release, 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, according to the press release.

The FDA approval is partially based on a 2-year, head-to-head phase 3 clinical trial in which researchers found that 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.

Ponesimod 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. These lesions are identified using magnetic resonance imaging technology and are classic measures of MS pathology, which can provide insights into disease activity and disease burden, according to the press release.

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