Ozanimod (Zeposia) has received TGA approval for use in relapsing remitting MS (RRMS) and has also received a favourable but deferred decision on PBS listing.
The drug is a sphingosine 1-phosphate receptor modulator that acts by preventing the movement of lymphocytes into the CNS to cause inflammation and myelin loss.
The TGA granted approval of the drug marketed by Celgene to the Australian Register of Therapeutic Goods (ARTG) on 17 July, based on studies showing that it was an effective and safe treatment to significantly reduce MS progression in people with relapsing remitting MS compared to interferon beta-1a.
Ozanimod has also received a favourable appraisal by the Pharmaceutical Benefits Advisory Committee (PBAC) for PBS listing at its March 2020 meeting, which concluded it “was of a mind to recommend the Authority Required (STREAMLINED) listing of ozanimod for the treatment of relapsing remitting multiple sclerosis (RRMS) on a cost minimisation basis with fingolimod.”
The PBAC noted that ozanimod offered a treatment alternative to fingolimod “and may have an additional safety benefit of reduced cardiac toxicity, meaning that first-dose cardiac monitoring is not required for ozanimod, in comparison to fingolimod.”
However the PBAC deferred a positive recommendation until the drug had received TGA approval.
MS Australia has advocated for PBS listing of ozanimod, noting that it as a once-daily oral tablet it would provide convenient option for people with relapsing remitting MS, particularly to those whom are located rurally and face a geographical barrier.