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Enspryng
Sponsor
Device/Product name
Enspryng
Active Ingredient
Satralizumab
Date of decision
Published
Submission type
New biological entity
ATC codes
L04AC19
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 Enspryng 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 | 2 December 2019 |
| First round evaluation completed | 3 June 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 26 June 2020 |
| Second round evaluation completed | 24 July 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 1 September 2020 |
| Sponsor's pre-Advisory Committee response | 14 September 2020 |
| Advisory Committee meeting | 1-2 October 2020 |
| Registration decision (Outcome) | 13 November 2020 |
| Completion of administrative activities and registration on ARTG | 17 November 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 220 |
*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
Solution for injection
Strength
120 mg/mL
Other ingredients
Histidine, aspartic acid, arginine, poloxamer 188, water for injections
Containers
Pre-filled syringe
Pack sizes
1 pre-filled syringe
Routes of administration
Subcutaneous
Dosage
Treatment should be initiated under the supervision of a physician experienced in the treatment of NMOSD.
Enspryng may be used as monotherapy or in combination with immunosuppressive therapy (IST) such as oral corticosteroids (OCs), azathioprine (AZA), or mycophenolate mofetil (MMF).
Loading dose
The recommended loading dose of Enspryng is 120 mg by subcutaneous injection (SC) every 2 weeks (first dose at week 0, second dose at week 2 and third dose at week 4) for the first three administrations.
Maintenance dose
The recommended maintenance dose is 120 mg SC every 4 weeks.
For further information refer to the Product Information.
Pregnancy category
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
Enspryng (satralizumab) was approved for the following therapeutic use:
Enspryng is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who have an anti-aquaporin 4 antibody (AQP4)-IgG (also termed NMO-IgG) positive status.
What is this medicine and how does it work
Satralizumab is a humanised immunoglobulin G2 (IgG2) monoclonal antibody (mAb) that binds to soluble and membrane-bound human interleukin 6 (IL-6) receptor (IL-6R) and thereby prevents IL-6 downstream signalling through these receptors. IL-6 is a pleiotropic cytokine produced by a variety of cell types and is involved in diverse processes such as B-cell activation, differentiation of B-cells to plasmablasts and production of autoantibodies, T-helper 17 (Th17)-cell activation and differentiation, T-regulatory cell inhibition, and changes in blood-brain barrier permeability. IL-6 levels are increased in cerebrospinal fluid and serum of patients with neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorders (NMOSD) during periods of disease activity. Some IL-6 functions have been implicated in the pathogenesis of NMO and NMOSD, including production of pathological autoantibodies against Aquaporin-4 (AQP4), a water channel protein mainly expressed by astrocytes in the central nervous system (CNS).
What post-market commitments will the sponsor undertake
- Enspryng (satralizumab) is to be included in the black triangle scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Enspryng 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 Enspryng European Union (EU)-risk management plan (RMP) (version 1.0, dated 30 July 2019; data lock point 18 July 2019), with Australian specific annex (version 1.2, dated August 2020), included with submission PM-2019-04752-1-1, to be revised to the satisfaction of 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 (Rev 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.
- All batches of Enspryng 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.
- For all injectable products the Product Information must be included with the product as a package insert.