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Velsipity (etrasimod)
Australian Prescription Medicine Decision Summary
Published
Product name
Velsipity
Active ingredient
Etrasimod
Submission type
Type A (New chemical entity)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Velsipity was approved for the treatment of adults with moderately to severely active ulcerative colitis who have had inadequate response, loss of response or intolerance to conventional, biologic or Janus kinase inhibitor therapies.
How this medicine works
Velsipity (etrasimod) blocks the function of proteins called sphingosine 1-phosphate (S1P) receptors (specifically S1P 1, 4 and 5). S1P receptors control the migration of lymphocytes. Through its blocking action on S1P receptors, Etrasimod partially and reversibly blocks the capacity of lymphocytes to move from lymph nodes to the intestines. Some types of lymphocytes cause inflammation. The exact mechanism by which etrasimod exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the intestines thereby limiting inflammation.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology studies conducted in animal models), clinical (pharmacology, safety and efficacy trials in humans) and risk management plan information submitted by the sponsor.
The main studies submitted for clinical evaluation were two randomised, double-blind, placebo-controlled, Phase 3 pivotal efficacy/safety studies, which were supported by two completed phase II studies.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.