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Saphnelo
Sponsor
Device/Product name
Saphnelo
Active Ingredient
Anifrolumab
Date of decision
Published
Submission type
New biological entity
ATC codes
L04AA51
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 Saphnelo 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 | 1 February 2021 |
| First round evaluation completed | 1 July 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 30 August 2021 |
| Second round evaluation completed | 18 October 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 4 January 2022 |
| Sponsor's pre-Advisory Committee response | 19 January 2022 |
| Advisory Committee meeting | 3 and 4 February 2022 |
| Registration decision (Outcome) | 24 March 2022 |
| Completion of administrative activities and registration on ARTG | 29 March 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 235 |
*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
Concentrate for solution for infusion
Strength
300 mg/2 mL
Other ingredients
Histidine, histidine hydrochloride monohydrate, lysine hydrochloride, trehalose dihydrate, polysorbate 80 and water for injections
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous
Dosage
The recommended dose of Saphnelo is 300 mg, administered as an intravenous infusion over a 30 minute period, every 4 weeks.
Treatment should be initiated and supervised by a physician experienced in the treatment of systemic lupus erythematosus (SLE).
For further information refer to the Product Information.
Pregnancy category
CDrugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.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
Saphnelo (anifrolumab) was approved for the following therapeutic use:
Saphnelo (anifrolumab) is indicated as add on treatment of adult patients with moderate to severe, active systemic lupus erythematosus (SLE), despite standard therapy.The safety and efficacy of Saphnelo have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.
What is this medicine and how does it work
Anifrolumab is a human immunoglobulin G1 kappa monoclonal antibody (IgG1κ) that binds to subunit 1 of the type I interferon receptor (IFNAR1) with high specificity and affinity. This binding inhibits type I IFN signalling thereby blocking the biological activity of type I IFNs. Anifrolumab also induces the internalisation of IFNAR1, thereby reducing the levels of cell surface IFNAR1 available for receptor assembly. Blockade of receptor mediated type I IFN signalling inhibits IFN responsive gene expression as well as downstream inflammatory and immunological processes. Inhibition of type I IFN blocks plasma cell differentiation and normalises peripheral T cell subsets, restoring the balance between adaptive and innate immunity that is dysregulated in multiple autoimmune disorders.Type I IFNs play an important role in the pathogenesis of systemic lupus erythematosus (SLE). Most adult patients with SLE (approximately 60 to 80%) express elevated levels of type I IFN inducible genes, which are associated with increased disease activity and severity.
What post-market commitments will the sponsor undertake
- Saphnelo (anifrolumab) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Saphnelo 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 Saphnelo European Union (EU)-risk management plan (RMP) (version 1 succession 3, dated 30 August 2021, data lock point 19 March 2020), with Australian specific annex (version 1.0 succession 3, dated 22 October 2021), included with Submission PM 2020 06383 1 2, 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.
- It is a condition of registration that all batches of Saphnelo (anifrolumab) imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- For all injectable products the Product Information must be included with the product as a package insert.