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Xembify
Sponsor
ARTGs
Device/Product name
Xembify
Active Ingredient
Normal immunoglobulin human
Date of decision
Published
Submission type
New biological entity
ATC codes
J06BA01
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 Xembify 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 | 31 March 2021 |
| First round evaluation completed | 31 August 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 28 October 2021 |
| Second round evaluation completed | 26 May 2022 |
| Delegate's overall benefit-risk assessment | 15 February 2022 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 22 June 2022 |
| Completion of administrative activities and registration on ARTG | 30 June 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 143 |
*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
2 g/10 mL (20%), 4 g/20 mL (20%), 1 g/5 mL (20%), and 10 g/50 mL (20%)
Other ingredients
Water for injections, glycine, and polysorbate 80
Containers
Vial
Pack sizes
One
Routes of administration
Subcutaneous injection
Dosage
Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. The dose and dose regimen are dependent on the indication.
In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.
For further information refer to the Product Information.
Pregnancy category
This therapeutic good is exempted from pregnancy categorisation.
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.
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
Xembify (normal immunoglobulin human) was approved for the following therapeutic use:
Indications for subcutaneous administration (SCIg)
Xembify is indicated as replacement therapy in adult and paediatric patients for:
- Primary immunodeficiency diseases (PID)
- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
What is this medicine and how does it work
Xembify supplies a broad spectrum of opsonising and neutralising immunoglobulin G (IgG) antibodies against bacteria and their toxins. The role of these antibodies and the mechanism of action of IgG in Xembify in primary immunodeficiency diseases (PID) has not been fully elucidated.
What post-market commitments will the sponsor undertake
- Xembify (human normal immunoglobulin) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Xembify 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 Xembify European Union (EU)-risk management plan (RMP) (version 2.0, dated 24 November 2020, data lock point 31 May 2020), with Australian specific annex (version 2.0, dated 13 December 2021), included with Submission PM-2020-06238-1-2, 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).
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 (revision 1), Part VII.B structures and processes.
Note that submission of a PSUR does not constitute an application to vary the registration.
- Batch Release Testing & Compliance with Certified Product Details (CPD)
All batches of Xembify normal immunoglobulin (Human) 20% solution for subcutaneous injection 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.