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Cibinqo (abrocitinib)
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Cibinqo
Active Ingredient
Abrocitinib
Date of decision
Published
Submission type
Type A (New chemical entity)
ATC codes
D11AH08: Agents for dermatitis, excluding corticosteroids
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.
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.
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.
What steps were involved in the decision process
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
Date of entry onto ARTG
Black triangle scheme
Cibinqo is to be included in the Black Triangle Scheme. The PI and CMI for Cibinqo 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.
Dose forms
Film coated tablet.
Strength
50 mg, 100 mg and 200 mg tablets
Other ingredients
Tablet core:
Film-coat
|
Containers
Blister packs containing 7 film coated tablet Starter Packs and 28 film coated tablet Commercial Packs
Pack sizes
Starter packs - 7 film coated tablets
Commercial packs - 28 film coated tablets
Commercial packs - 28 film coated tablets
Routes of administration
Oral
Dosage
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.
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.
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.
What was approved
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.
What is this medicine and how does it work
Cibinqo (abrocitinib) is a Janus kinase (JAK) 1 inhibitor. JAKs are enzymes within cells with roles in haematopoiesis (the development of the cellular components of blood) and immune cell function. JAKs activate Signal Transducers and Activators of Transcription (STATs). STATs are transcription factors, proteins that regulate gene expression. The JAK-STAT signaling pathway is a key mediator of inflammatory signals. In atopic dermatitis, there is excessive inflammation in the skin. Multiple studies have demonstrated the importance of the JAK/STAT pathway in inflammatory conditions like atopic dermatitis. Abrocitinib mediates its therapeutic effect by inhibiting JAK1 and reducing skin inflammation associated with atopic dermatitis.
What post-market commitments will the sponsor undertake
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.