We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Litfulo (ritlecitinib)
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Litfulo
Active Ingredient
ritlecitinib
Date of decision
Published
Submission type
Type A - New chemical entity
ATC codes
L04AF Janus-associated kinase (JAK) inhibitors
Decision
Approved
What was the decision based on
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)
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)
What steps were involved in the decision process
This submission was evaluated under the standard prescription medicines registration process.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 November 2023 |
| Evaluation completed | 20 May 2024 |
| Delegate’s1 Overall benefit-risk assessment | 17 June 2024 |
| Registration decision (Outcome) | 26 June 2024 |
| Administrative activities and registration in the ARTG completed | 9 July 2024 |
| Number of working days from submission dossier acceptance to registration decision2 | 151 |
1. The ‘Delegate’ is the Delegate of the Secretary of the Department of Health and Aged Care who made the final decision to either include the new medicine/indication on the ARTG or reject the submission, under section 25 of the Therapeutic Goods Act.
2. Statutory timeframe for standard submissions is 255 working days
Date of entry onto ARTG
Black triangle scheme
Litfulo is to be included in the Black Triangle Scheme. The PI and CMI for Litfulo must include the black triangle symbol ▼ for five years. The black triangle is a visual reminder to encourage health practitioners and patients to report a problem or side effect with this medicine.
Dose forms
Hard capsule (capsule).
Strength
Each hard capsule contains ritlecitinib tosylate 80.128 mg, equivalent to ritlecitinib 50 mg
Other ingredients
Hard capsule content
• Microcrystalline cellulose
• Lactose monohydrate
• Crospovidone
• Glycerol dibehenate
Hard capsule shell
• Hypromellose
• Titanium dioxide
• Iron oxide yellow
• Brilliant Blue FCF
Printing ink: Capsugel Ink 10A2 Black (Proprietary Ingredient ID 109521)
• Shellac
• Propylene glycol
• Strong ammonia solution
• Iron oxide black
• Potassium hydroxide
Containers
High-density polyethylene (HDPE) bottle with a silica gel desiccant and polypropylene child resistant closure containing 28 hard capsules.
Pack sizes
10 capsules (starter pack) or 30 capsules.
Routes of administration
Oral
Dosage
The recommended dose of Litfulo is 50 mg once daily.
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.
Ritlecitinib is not recommended in women of childbearing potential not using contraception. Women of childbearing potential have to use effective contraception during treatment and for 1 month following the final dose of Litfulo.
Ritlecitinib is not recommended in women of childbearing potential not using contraception. Women of childbearing potential have to use effective contraception during treatment and for 1 month following the final dose of Litfulo.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
Litfulo is to be included in the Black Triangle Scheme. The PI and CMI for Litfulo must include the black triangle symbol and mandatory accompanying text for five years. The Black Triangle Scheme identifies new prescription medicines with a black triangle on the medicine information documents. The black triangle is a visual reminder to encourage health practitioners and patients to report a problem or side effect associated with this medicine.
The Litfulo EU-Risk Management Plan (RMP) (version 1.2, date 18 July 2023) with Australia-specific Annex (version 1.1, date 12 April 2024), as agreed with the TGA will be implemented in Australia. An obligatory component of risk management plans is routine pharmacovigilance which 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.