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Cibinqo (abrocitinib)
Australian Prescription Medicine Decision Summary
Published
Product name
Cibinqo
Active ingredient
Abrocitinib
Submission type
Type A (New chemical entity)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
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.
How this medicine works
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.
Why the TGA approved or did not approve this medicine
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.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlink below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlink below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
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For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.