Omvoh
Registration timeline
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland-United Kingdom (ACCESS) Consortium, with work-sharing between TGA and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
The following table summarises the key steps and dates for this application.
|
Description |
Date |
|---|---|
|
Submission dossier accepted and first round evaluation commenced
|
28 July 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
21 June 2023 |
|
Advisory Committee meeting |
3 and 4 August 2023
|
|
Registration decision (Outcome) |
26 September 2023
|
|
Completion of administrative activities and registration on ARTG |
27 September 2023
|
|
Number of working days from submission dossier acceptance to registration decision* |
191 |
*Statutory timeframe for standard applications is 255 working days
Citric acid, sodium chloride, sodium citrate dihydrate, polysorbate 80, water for injections.
2, 4, 6 autoinjector and pre-filled syringe
Therapy with Omvoh is intended for use under the guidance and supervision of a healthcare professional experienced in the diagnosis and treatment of ulcerative colitis.
Omvoh is single use in one patient on one occasion only.
Recommended dose regimen is different for induction and maintenance dose.
For further information refer to the Product Information.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Omvoh is indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a biological medicine, or have medical contraindications to such therapies.
Interleukin-23 is an important driver of mucosal inflammation in ulcerative colitis and affects the differentiation, expansion, and survival of T-cell subsets, and innate immune cell subsets, which represent sources of pro-inflammatory cytokines. Research in animal models has shown that genetic deletion or pharmacological inhibition of IL-23 p19 can ameliorate or prevent intestinal inflammation.
- Omvoh (mirikizumab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Omvoh 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 Omvoh EU [European Union]-risk management plan (RMP) (version 0.4, date 28 March 2023; DLP [data lock point] 6 December 2021), with Australia specific annex (version 1.2, 4 April 2023), included with Submission PM-2022-02424-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency’s Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- Laboratory testing & compliance with Certified Product Details (CPD)
- All batches of Omvoh mirikizumab supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- When requested by the TGA, the Sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
- Certified Product Details
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website
[for the form]
[for the CPD guidance]
- For the following injectable products the Product Information must be included with the product as a package insert: AUST R 391347 - Omvoh mirikizumab 100 mg/mL solution for injection autoinjector and AUST R 391348 - Omvoh mirikizumab 100 mg/ mL solution for injection pre-filled syringe.
Further information
The latest Product Information (PI) and Consumer Medicines 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.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.