Velsipity (etrasimod)
Australian Prescription Medicine Decision Summary
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.
This submission was evaluated under the standard prescription medicines registration process.
The following table summarises the key steps and dates for this application:
| Registration process step | Date |
|---|---|
| Dossier accepted and first round evaluation commenced | 31 March 2023 |
| First round evaluation completed | 7 September2023 |
| Second round evaluation completed | 22 December 2023 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 2 January 2024 |
| Sponsor’s pre-Advisory Committee response | 16 January 2024 |
| ACM Meeting | 23 April 2024 |
| Registration decision (Outcome) | 17 May 2024 |
| Administrative activities and registration in the ARTG completed | 22 May 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 246 |
*Statutory timeframe for standard submissions is 255 working days
• Magnesium stearate
• Mannitol
• Microcrystalline cellulose
• Sodium starch glycollate type A
• Opadry® II Complete Film Coating System 85F110190-CN Green (ID: 144806)
-high-density polyethylene (HDPE) bottles closed with a child-resistant polypropylene cap and packaged inside an outer carton.
-aluminum strip laminated to an oriented polyamine (oPA) film and integrated desiccant layer (HDPE/LDPE) with a paper/aluminum/LDPE backing.
Bottle: 30 tablets
2 mg taken orally once daily.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects.
There are no adequate and well-controlled studies on the developmental risk associated with the use of VELSIPITY in pregnant women. VELSIPITY should not be used during pregnancy.
In animal studies, administration of etrasimod during pregnancy produced adverse effects on development, including embryolethality and fetal malformations, in both rats and rabbits at clinically relevant maternal exposures.
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.
Velsipity is to be included in the Black Triangle Scheme. The PI and CMI for Velsipity must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product. The Velsipity Risk Management Plan (RMP) as agreed with the TGA will be implemented in Australia. An obligatory component of RMPs is routine pharmacovigilance, which includes the submission of periodic safety update reports (PSURs).
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
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