Ponvory for the treatment of adults with relapsing forms of multiple sclerosis with active disease - Approved in European Union
The European Commission ( EC ) has approved Ponvory ( Ponesimod ) for the treatment of adult patients with relapsing multiple sclerosis ( RMS ) with active disease defined by clinical or imaging features.
The EC approval of Ponvory is based on data from the phase 3 OPTIMUM trial, a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients ( aged 18-55 years ) in 28 countries.
The trial was designed to evaluate the efficacy and safety of once daily oral Ponesimod ( 20mg ) versus once-daily Teriflunomide ( 14mg ), an approved and widely-used first-line oral treatment, in adult patients with relapsing multiple sclerosis.
The large, phase 3 study has shown superior efficacy of Ponesimod 20mg on the primary endpoint, annualised relapse rate ( ARR ), with a rate reduction of 30.5% ( p less than 0.001 ) compared with Teriflunomide.
Ponesimod has also shown statistically significant superiority on one of the secondary endpoints, combined unique active lesions ( CUALs ).
Ponesimod has significantly reduced the number of new inflammatory lesions on brain MRI by 56% ( p less than 0.0001 ) at week 108 when compared to Teriflunomide.
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.
The most commonly reported adverse events in either the Ponesimod 20mg group versus the Teriflunomide 14mg group were alanine aminotransferase ( ALT ) enzyme elevations ( 19.5% vs 9.4% ), nasopharyngitis ( 19.3% vs 16.8% ), headache ( 11.5% vs 12.7% ), upper respiratory tract infection ( 10.6% vs 10.4% ) and alopecia ( 3.2% vs 12.7% ).
The safety profile of Ponesimod is consistent with the known safety profile of other S1P receptor modulators, although a head-to-head comparison, other than with Teriflunomide, is not available.
Ponesimod is an oral, highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.
In patients with multiple sclerosis, inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Damage to myelin slows or halts nerve conduction, producing the neurologic signs and symptoms of multiple sclerosis.
Multiple sclerosis is a chronic autoimmune inflammatory disease of the central nervous system ( CNS ). Symptoms vary by person, but common symptoms include fatigue, balance and walking problems, numbness or tingling, dizziness and vertigo, vision problems, bladder and bowel problems and weakness. ( Xagena )
Source: Janssen, 2021
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