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Ledaga
Device/Product name
Ledaga
Active Ingredient
Chlormethine hydrochloride
Date of decision
Published
Submission type
New chemical entity
ATC codes
L01AA05
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. The benefit-risk profile of Ledaga was considered favourable for the therapeutic use approved.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Designation: Orphan Extension | 15 August 2019 4 December 2019 |
| Submission dossier accepted and first round evaluation commenced | 31 July 2020 |
| First round evaluation completed | 24 December 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 2 March 2021 |
| Second round evaluation completed | 13 April 2021 |
| Delegate's overall benefit-risk assessment | 15 April 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 8 June 2021 |
| Completion of administrative activities and registration on ARTG | 22 June 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 170 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Gel
Strength
160 µg/g chlormethine
Other ingredients
Diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerol, lactic acid, hyprolose, sodium chloride, menthol, disodium edetate, butylhydroxytoluene
Containers
Tube
Pack sizes
One
Routes of administration
Topical
Dosage
Treatment with Ledaga should be initiated by an appropriately experienced physician.
A thin film of Ledaga should be applied once daily to affected areas of the skin.
Treatment with Ledaga should be stopped for any grade of skin ulceration or blistering, or moderately severe or severe dermatitis (for example, marked skin redness with oedema). Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every three days. If reintroduction of treatment is tolerated for at least one week, the frequency of application can be increased to every other day for at least one week and then to once-daily application if tolerated.
Elderly
The dosing recommendation for elderly patients (≥ 65 years old) is the same as for younger adult patients (see Section 4.8 in the Product Information).
For further information refer to the Product Information.
Pregnancy category
B3Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humansThe use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
Ledaga (chlormethine hydrochloride) was approved for the following therapeutic use:
Ledaga is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
What is this medicine and how does it work
Chlormethine is a bifunctional alkylating agent that reacts with deoxyribonucleic acid to form cross-links, inducing the death of rapidly proliferating cells.
What post-market commitments will the sponsor undertake
- Ledaga (chlormethine) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Ledaga 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.
- The Ledaga European Union (EU)-Risk Management Plan (RMP) (version 2.0, dated 8 March 2017, data lock point 22 February 2016), with Australian specific annex (version 2.0, dated 19 April 2021), included with submission 2020-03014-1-6, and any subsequent revisions, as agreed 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.