Cutaquig
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 30 April 2020 |
| First round evaluation completed | 30 September 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 30 November 2020 |
| Second round evaluation completed | 12 January 2021 |
| Delegate's overall benefit-risk assessment | 25 March 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 21 April 2021 |
| Completion of administrative activities and registration on ARTG | 3 May 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 199 |
*Statutory timeframe for standard applications is 255 working days
Replacement therapy should be initiated under the supervision of a healthcare professional experienced in the treatment of immunodeficiency.
In replacement therapy the dosage may need to be individualised for each patient dependent on the pharmacokinetic and clinical response.
For further information refer to the Product Information.
Cutaquig (human normal immunoglobulin) was approved for the following therapeutic use:
Replacement therapy in adults and children in:
- Primary immunodeficiency diseases (PID)
- Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment
- Cutaquig (human normal immunoglobulin) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Cutaquig 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 Cutaquig European Union (EU)-risk management plan (RMP) (version 01.3, dated 12 December 2018, data lock point 31 October 2018), with Australian specific Annex (version 01, dated 1 April 2020), included with submission PM-2020-00473-1-2, 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 (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- It is a condition of registration that all batches of Cutaquig imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
- It is a condition of registration that up to 5 initial batches of Cutaquig imported into/manufactured in Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results.
- The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry Testing for specific material requirements related to batch release testing/assessment of the product.
- For all injectable products the Product Information must be included with the product as a package insert.