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Ponvory
Published
Product name
Ponvory
Active ingredient
Ponesimod
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ponvory (ponesimod) was approved for the following therapeutic use:
Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
How this medicine works
Ponesimod is a sphingosine 1 phosphate (S1P) receptor 1 modulator. Ponesimod binds with high affinity to S1P receptor 1, which is expressed on a range of cell types including lymphocytes. Ponesimod blocks the capacity of lymphocytes to egress from lymph nodes reducing the number of lymphocytes in peripheral blood. The mechanism by which ponesimod exerts therapeutic effects in multiple sclerosis may involve reduction of lymphocyte migration into the central nervous system.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Ponvory was considered favourable for the therapeutic use approved.
Sponsor