We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Litfulo (ritlecitinib)
Australian Prescription Medicine Decision Summary
Published
Product name
Litfulo
Active ingredient
ritlecitinib
Submission type
Type A - New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Litfulo (ritlecitinib) has been approved for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older. Alopecia areata is an autoimmune disease that causes hair loss.
How this medicine works
Ritlecitinib inhibits the activity of multiple enzymes known as kinases. Kinases alter the activity of other proteins by linking a chemical called a phosphate group to them. Ritlecitinib irreversibly and selectively inhibits an enzyme called Janus kinase (JAK) 3 as well as all members of the TEC family of kinases. There is evidence that JAK3 and TEC family kinases are are both involved in causing alopecia areata, possibly via immune cell activation, although the causes of alopecia areata are not completely understood. It is thought that blocking JAK3 and TEC kinases by ritlecitinib prevents the production of inflammatory chemicals (called cytokines) and reduces the cell killing ability of some immune cells and that these functions play a role in relieving the symptoms of alopecia areata. However, the full relevance of the inhibition of these kinases to the therapeutic effectiveness of ritlecitinib is not currently known.
Why the TGA approved or did not approve this medicine
The approval was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan data submitted to the TGA by the Sponsor.
The effectiveness and safety of ritlecitinib was demonstrated in a randomised, double-blind, placebo-controlled clinical trial in 718 alopecia areata patients 12 years of age and older with greater than 50% scalp hair loss. A significantly greater proportion of patients achieved improvements in their symptoms with ritlecitinib compared to placebo (In this type of trial, study subjects are randomly assigned to either a treatment or a placebo group; neither the study participants nor the medical personnel know who is receiving the treatment or the placebo)
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 hyperlinks 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 hyperlinks below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
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.