The therapy was approved by the U.S. Food and Drug Administration (FDA) in March 2021 for the treatment of adults with relapsing MS forms, including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
Janssen submitted a regulatory filing seeking approval for ponesimod in the European Union in March 2020. The application is under review.
Ponvory is a once-daily oral therapy. Beginning treatment may result in a decrease in heart rate, so first-dose monitoring is recommended in patients with certain preexisting cardiac conditions.
How does Ponvory work?
Ponvory is a selective S1P1 immunomodulator. By blocking S1P signaling, the therapy is believed to stop immune cells (lymphocytes) from leaving lymph nodes (immune-related structures). This reduces the number of circulating immune cells, preventing them from infiltrating in target issues.
In people with relapsing MS, ponesimod is thought to prevent lymphocytes from crossing the blood-brain barrier and entering the central nervous system, where they could cause damage to myelin — the protective sheath that insulates nerve fibers and is damaged in patients with MS.
Immune cell count reduction is rapid, dose-dependent, and maintained with continued dosing. Ponvory’s effect is reversible, wearing off within one or two weeks after discontinuation.
Ponvory in clinical trials
Earlier studies showed promising results. Ponvory was tested at different doses — 10 mg, 20 mg, and 40 mg — in a Phase 2 study (NCT01006265). Results showed that ponesimod significantly reduced the number of new active lesions on MRI brain scans and reduced the frequency of relapses. An extension study (NCT01093326) confirmed the findings.
A Phase 3 study, called OPTIMUM (NCT02425644), compared the effectiveness and safety of Ponvory to Aubagio (teriflunomide) in adults with RRMS or active SPMS. Aubagio is an approved oral therapy for MS.
The study included 1,133 participants, who were treated with either Ponvory (20 mg per day), or Aubagio (14 mg per day), for 108 weeks. Results showed that Ponvory was superior to Aubagio in significantly reducing the annualized relapse rates — a 30.5% relative reduction. Ponvory also was superior to Aubagio in reducing the number of MRI lesions and easing fatigue, and prevented disability from worsening in most people.
The most reported side effects for Ponvory are upper respiratory tract infections, elevated liver enzymes (abnormal liver tests), and high blood pressure (hypertension).
It is not known yet if Ponvory is safe and effective in children.
Last updated: March 19, 2021
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