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Find Clinical Drug Pipeline Developments & Deals for Ponesimod
Through the acquisition, Juvise Pharmaceuticals will leverage its expertise to commercialize and develop Ponvory(ponesimod), a first-line treatment option in active forms of relapsing multiple sclerosis, outside of the United States and Canada, with a focus on Europe.
Through the acquisition, Vanda expands its commercial portfolio by including Ponvory (ponesimod), a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of multiple sclerosis.
The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod 20mg vs. once per day teriflunomide 14mg, an approved first-line oral treatment, in adult patients with RMS. In total, 1,133 adult patients were randomised at 162 sites in 28 countries.
PONVORY™, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, approved to treat adults with relapsing forms of MS in both the United States and European Union earlier this year.
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.
Positive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis.
Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide. PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator.
Head-to-head OPTIMUM Phase 3 study showed superior efficacy of ponesimod 20 mg on the primary endpoint as well as most secondary endpoints, compared to Aubagio® (teriflunomide).