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Spevigo
Sponsor
Device/Product name
Spevigo
Active Ingredient
Spesolimab
Date of decision
Published
Submission type
New biological entity
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 Spevigo 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) | 14 January 2022 |
Submission dossier accepted and first round evaluation commenced | 30 June 2022 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 29 June 2023 |
Advisory Committee meeting | 3 and 4 August 2023 |
Registration decision (Outcome) | 5 September 2023 |
Completion of administrative activities and registration on ARTG | 24 November 2023 |
Number of working days from submission dossier acceptance to registration decision* | 226 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes
Dose forms
Solution for infusion.
Strength
450 mg/7.5 mL (60 mg/mL)
Containers
Vial
Pack sizes
2
Routes of administration
Intravenous
Dosage
Treatment with Spevigo should be initiated and supervised by physicians experienced in the management of patients with inflammatory skin diseases.
The recommended dose of Spevigo is a single dose of 900 mg (2 x 450 mg/7.5 mL vials) administered as an intravenous infusion. If flare symptoms persist, an additional 900 mg dose may be administered one week after the initial dose.
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. The pregnancy database 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. The pregnancy database 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
Spevigo (spesolimab) was approved for the following therapeutic use:
Spevigo is indicated for the treatment of flares in adult patients with generalised pustular psoriasis.
What is this medicine and how does it work
Spesolimab is a humanised antagonistic monoclonal immunoglobulin G1 (IgG1) antibody blocking human interleukin-36 receptor (IL36R) signalling. Binding of spesolimab to IL36R prevents the subsequent activation of IL36R by cognate ligands (IL36 α, β and γ) and downstream activation of pro inflammatory and pro-fibrotic pathways. IL36R signalling is differentiated from tumour necrosis factor alpha (TNF-α), integrin and interleukin-23 (IL-23) inhibitory pathways by directly and simultaneously blocking both inflammatory and pro-fibrotic pathways. Genetic human studies have established a strong link between IL36R signalling and skin inflammation.
Following treatment with Spevigo in patients with generalised pustular psoriasis (GPP), reduced levels of C-reactive protein (CRP), interleukin (IL)-6, T-helper cell (Th1/Th17) mediated cytokines, keratinocyte-mediated inflammation, neutrophilic mediators, and proinflammatory cytokines were observed in serum and skin at Week 1 compared to Baseline and was associated with a decrease in clinical severity. These reductions in biomarkers became more pronounced at the last measurement at Week 8 in Effisayil-1.
Following treatment with Spevigo in patients with generalised pustular psoriasis (GPP), reduced levels of C-reactive protein (CRP), interleukin (IL)-6, T-helper cell (Th1/Th17) mediated cytokines, keratinocyte-mediated inflammation, neutrophilic mediators, and proinflammatory cytokines were observed in serum and skin at Week 1 compared to Baseline and was associated with a decrease in clinical severity. These reductions in biomarkers became more pronounced at the last measurement at Week 8 in Effisayil-1.
What post-market commitments will the sponsor undertake
- Spevigo (spesolimab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Spevigo 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 Spevigo EU [European Union]-risk management plan (RMP) (version 1.0, dated 6 October 2022, data lock point 8 January 2021), with Australia-specific annex (version 0.2, dated 31 January 2023), included with Submission PM-2022-01272-1-1, 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).
- 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.
- Laboratory testing and compliance with Certified Product Details (CPD)
- All batches of Spevigo (spesolimab) (rch) 450 mg in 7.5 mL concentrated solution for infusion, vial supplied in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- When requested by the TGA, the sponsor should be prepared to provide product samples, specified reference materials and documentary evidence to enable the TGA to conduct laboratory testing on the Product. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results and periodically in testing reports on the TGA website.
- Certified Product Details
- The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- A template for preparation of CPD for biological prescription medicines can be obtained from the TGA website [for the form] [for the CPD guidance]
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.