Alhemo
Registration timeline
The following table summarises the key steps and dates for this application.
|
Description |
Date |
|---|---|
|
Submission dossier accepted and first round evaluation commenced
|
29 September 2022 |
|
Delegate’s Overall benefit-risk assessment |
29 August 2023 |
|
Advisory Committee meeting |
Not applicable |
|
Registration decision (Outcome) |
13 September 2023 |
|
Completion of administrative activities and registration on ARTG |
18 September 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
218 |
*Statutory timeframe for standard applications is 255 working days
Arginine hydrochloride, histidine, hydrochloric acid, phenol, polysorbate 80, sodium chloride, sodium hydroxide, sucrose, and water for injections.
Treatment should be initiated under the supervision of a physician experienced in treatment of haemophilia and/or bleeding disorders.
Initiate concizumab in a non-bleeding state, and after discontinuing treatment with bypassing agents. Discontinue rFVIIa at least 12 hours before starting concizumab therapy. Discontinue activated prothrombin complex concentrate (aPCC) at least 48 hours before starting concizumab therapy.
For further information refer to the Product Information.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. 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.
Alhemo (concizumab) was approved for the following therapeutic use:
Alhemo is indicated where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have:
- haemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors
The full indications are now:
Alhemo is indicated where prophylaxis is required to prevent or reduce the frequency of bleeding in patients at least 12 years of age who have:
- haemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors
- haemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors
As concizumab acts independently from FVIII and FIX, the effect of concizumab is not expected to be influenced by the presence of inhibitory antibodies to FVIII or FIX.
As concizumab has no structural relationship or sequence homology to FVIII or FIX, it is not expected to induce or enhance the development of direct inhibitors to FVIII or FIX.
- Alhemo (concizumab) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Alhemo 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 Alhemo EU [European Union]-risk management plan (RMP) (version 0.1, dated 8 December 2022; data lock point 30 August 2022), with Australia specific annex (version 0.3, dated 2 June 2023), included with Submission PM-2022-03459-1-6, 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.
- For all injectable products the Product Information must be included with the product as a package insert.
Further information
The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.