Cibinqo (abrocitinib)
In clinical trials, the efficacy and safety of Cibinqo as monotherapy and in combination with background medicated topical therapies over 12-16 weeks were evaluated in 3 pivotal Phase 3 randomised, double-blind, placebo-controlled studies. In addition, the efficacy and safety of Cibinqo in monotherapy over 52 weeks (with the option of rescue treatment in flaring subjects) was evaluated in a Phase 3 induction, randomised withdrawal, double-blind, placebo-controlled study.
The benefit-risk profile of CIBINQO was considered favourable for the therapeutic use approved.
This submission was evaluated under the standard prescription medicines registration process.
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 November 2020 |
| First round evaluation completed | 18 May 2021 |
| Second round evaluation completed | 22 November 2021 |
| Delegate’s overall benefit-risk assessment and request for Advisory Committee advice | 27 October 2021 |
| Advisory Committee meeting 1 | December 2021 |
| Advisory Committee meeting 2 | April 2022 |
| Registration Decision (Rejection) | 13 September 2022 |
| Review sought of the initial decision under section 60 of the Therapeutic Goods Act. | 18 October 2022 |
| Registration decision - Approval (Administrative Appeals Tribunal outcome) | 12 April 2024 |
| Administrative activities and registration in the ARTG completed | 16 April 2024 |
| Number of working days from submission dossier acceptance to registration decision* | 858 days |
*Statutory timeframe for standard applications is 255 working days
Tablet core:
Film-coat
|
Commercial packs - 28 film coated tablets
The recommended starting dose is 100 mg or 200 mg once daily based on individual patient characteristics:
- A starting dose of 100 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE) and malignancy.
- A dose of 200 mg once daily may be appropriate for patients with high disease burden who are not at higher risk of VTE, MACE and malignancy or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered.
The lowest effective dose for maintenance should be considered.
Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.
Cibinqo can be used with or without medicated topical therapies for atopic dermatitis.
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.
Cibinqo has been approved for the treatment of moderate-to-severe atopic dermatitis in adults who are candidates for systemic therapy. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis.
The Cibinqo Risk Management Plan (RMP), as negotiated 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).
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.