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Onakta (tirbanibulin)
Sponsor
Device/Product name
Onakta
Active Ingredient
Tirbanibulin
Date of decision
Published
Submission type
New chemical entity
Decision
Approved
What was the decision based on
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 Onakta was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced | 18 August 2022 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 4 July 2023
|
Advisory Committee meeting | 3 and 4 August 2023
|
Registration decision (Outcome) | 19 September 2023
|
Completion of administrative activities and registration on ARTG | 23 February 2024
|
Number of working days from submission dossier acceptance to registration decision* | 229
|
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes
Dose forms
Ointment
Strength
10 mg/g
Containers
Sachet
Pack sizes
One and 5
Routes of administration
Topical
Dosage
Apply a thin layer of ONAKTA® to evenly cover the treatment field of up to 25 cm2 on the face or scalp once daily for 5 consecutive days using 1 single-dose sachet per application. If a dose is missed, the patient should apply the ointment as soon as they remember and then continue with the regular schedule. However, the ointment should not be applied more than once a day.
Pregnancy category
D
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. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database 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.
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. Accompanying texts should be consulted for further details.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database 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.
What was approved
Onakta (tirbanibulin) was approved for the following therapeutic use:
Onakta is indicated for the topical field treatment of non-hyperkeratotic, nonhypertrophic actinic keratosis of the face or scalp in adults.
What is this medicine and how does it work
Tirbanibulin disrupts microtubules by direct binding to tubulin, which induces cell cycle arrest and apoptotic death of proliferating cells and is associated with disruption of Src tyrosine kinase signalling.
What post-market commitments will the sponsor undertake
- Onakta (tirbanibulin) is to be included in the Black Triangle Scheme. The PI [Product Information and CMI [Consumer Medicine Information] for Onakta 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 Onakta EU [European Union]-risk management plan (RMP) (version 0.7, dated 10 May 2021, data lock point 10 October 2019), with Australia-specific annex (version 2.0, dated 10 March 2023), included with Submission PM-2022-02492-1-1, 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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.
- Submission of the results of the ongoing, EU 3-year safety study (PASS) to the TGA, when available.
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.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.