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Sotyktu
Device/Product name
Sotyktu
Active Ingredient
Deucravacitinib
Date of decision
Published
Submission type
New chemical entity
ATC codes
L04AA56
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 Sotyktu 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 |
|
Submission dossier accepted and first round evaluation commenced |
30 November 2021 |
|
First round evaluation completed |
9 May 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
30 June 2022 |
|
Second round evaluation completed |
18 August 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
9 September 2022 |
|
Sponsor’s pre-Advisory Committee response |
23 September 2022 |
|
Advisory Committee meeting |
6 and 7 October 2022 |
|
Registration decision (Outcome) |
29 November 2022 |
|
Completion of administrative activities and registration on ARTG |
1 December 2022 |
|
Number of working days from submission dossier acceptance to registration decision* |
222 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
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
Film coated tablet
Strength
6 mg
Other ingredients
Croscarmellose sodium, hypromellose acetate succinate, iron oxide red, iron oxide yellow, lactose, macrogol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, purified talc, silicon dioxide and titanium dioxide.
Containers
Blister pack
Pack sizes
7 and 28
Routes of administration
Oral
Dosage
The recommended dose of Sotyktu is 6 mg once daily taken orally, with or without food. Do not crush, cut, or chew the tablet.
For further information refer to the Product Information.
Pregnancy category
B1
Drugs 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 not shown evidence of an increased occurrence of fetal damage.
The 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.
Drugs 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 not shown evidence of an increased occurrence of fetal damage.
The 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
Sotyktu (deucravacitinib) was approved for the following therapeutic use:
Sotyktu is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
What is this medicine and how does it work
Deucravacitinib is a small molecule that selectively inhibits the tyrosine kinase 2 (TYK2) enzyme. Deucravacitinib binds to the regulatory domain of TYK2, stabilising an inhibitory interaction between the regulatory and the catalytic domains of the enzyme. This results in allosteric inhibition of receptor-mediated activation of TYK2 and its downstream functions in cells. TYK2 is a member of the Janus kinase (JAK) family. JAK kinases, including TYK2, function in pairs to mediate Janus kinase-signal transducer and activator of transcription [JAK-STAT] pathways. TYK2 pairs with JAK1 to mediate multiple cytokine pathways and also pairs with JAK2 to transmit signals. The pairing of TYK2 with either JAK1 or JAK2 mediates signalling of a narrower range of cytokines compared with the pairings of JAKs 1/2/3 with each other. The allosteric mechanism of action of deucravacitinib has been shown to inhibit TYK2 with minimal or no inhibition of JAK 1/2/3. TYK2 mediates signalling of interleukin-23 (IL-23) cytokine, interleukin-12 (IL-12) cytokine, and type I interferons (IFN), which are naturally occurring cytokines involved in inflammatory and immune responses. Deucravacitinib inhibits signalling from IL-23, IL-12 and type I IFN and the downstream release of proinflammatory cytokines and chemokines.
What post-market commitments will the sponsor undertake
- Sotyktu (deucravacitinib) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Sotyktu 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 Sotyktu (deucravacitinib) EU [European Union] - risk management plan (RMP) (version 1.0, dated 02 September 2021, data lock point 15 June 2021), with Australian specific annex (version 1.0, dated 20 September 2021), included with Submission PM-2021-04758-1-1, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report 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 (revision 1), Part VII.B Structures and processes.
Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.