Enspryng
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
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.
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.
- 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.