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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New biological entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
3 September 2021
|Date of entry onto ARTG|| |
10 September 2021
|Original publication date|| |
17 September 2021
|ARTG numbers|| |
340793, 340796 and 340797
|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
Kyowa Kirin Australia Pty Ltd
|Sponsor address|| |
Level 7, 68 York Street, NSW 2000
|Dose forms|| |
Solution for injection
10 mg/mL, 20 mg/mL and 30 mg/mL
|Other ingredients|| |
L-histidine, D-sorbitol, polysorbate 80, L-methionine, 10% hydrochloric acid (for pH adjustment), water for injection
|Pack sizes|| |
|Routes of administration|| |
Treatment should be initiated and monitored by specialist medical practitioners experienced in the management of patients with metabolic bone disease.
Dosage of Crysvita is based on multiple factors, including the age, the body weight and the serum phosphate concentration of the patient.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
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.
Crysvita (burosumab) was approved for the following therapeutic use:
Crysvita (burosumab) is indicated for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents and children 1 year of age or older.
The following table summarises the key steps and dates for this application, evaluated through Priority Review.
|Priority Designation||16 July 2020|
|Orphan Designation||16 July 2020|
|Submission dossier accepted and first round evaluation commenced||7 September 2020|
|Evaluation completed||19 February 2021|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||9 March 2021|
|Sponsor's pre-Advisory Committee response||24 March 2021|
|Advisory Committee meeting||8 and 9 April 2021|
|Registration decision (Outcome)||3 September 2021|
|Completion of administrative activities and registration on ARTG||10 September 2021|
|Number of working days from submission dossier acceptance to registration decision*||143|
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
- Crysvita (burosumab) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Crysvita 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 Crysvita European Union (EU)-Risk Management Plan (RMP) (version 2.1, dated 31 March 2020; data lock point 18 February 2019), with Australian Specific annex (version 1.3, dated 26 February 2021), included with submission PM-2020-03892-1-5, 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.
- Laboratory testing & compliance with Certified Product Details
- All batches of CRYSVITA 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.
Certified Product Details
The CPD, as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- The sponsor is required to update the relevant Good Manufacturing Practice (GMP) clearances to reflect the appropriate steps in the manufacturing process included in the ARTG record. This could be done at the next time a GMP clearance is required but should be completed within the next 12 months.
- For all injectable products the Product Information must be included with the product as a package insert