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Zeposia
Published
Product name
Zeposia
Active ingredient
Ozanimod
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Zeposia (ozanimod) was approved for the following therapeutic use:
Zeposia is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.
How this medicine works
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator, which binds with a high affinity to sphingosine 1-phosphate receptor subtypes 1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis (MS) is unknown but may involve the reduction of lymphocyte migration into the central nervous system. Ozanimod is 10 fold more selective for S1P1 relative to S1P5 and has little activity on other S1P receptors (S1P2, S1P3, and S1P4). Ozanimod is extensively metabolized in humans to form a number of circulating active metabolites. In vitro, ozanimod and its active metabolites demonstrated similar activity and selectivity for S1P1 and S1P5. In humans, approximately 94% of circulating total active drug exposure is represented by ozanimod (6%) and major human metabolites, CC112273 (73%), and CC1084037 (15%).
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 Zeposia was considered favourable for the therapeutic use approved.
Sponsor
ARTG details
- 318800, 318801
- 318800, 318801