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ARTGs
340793, 340796 and 340797
340793, 340796 and 340797
340793, 340796 and 340797
Device/Product name
Crysvita
Active Ingredient
Burosumab
Date of decision
Published
Submission type
New biological entity
ATC codes
M05BX05
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 Crysvita 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, evaluated through Priority Review.

Description Date
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.

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
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
Containers
Vial
Pack sizes
One
Routes of administration
Subcutaneous injection
Dosage

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
B3Drugs 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.
What was approved

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.
What is this medicine and how does it work
Burosumab is a recombinant human monoclonal immunoglobulin G1 (IgG1) antibody that binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23), present in excess in X-linked hypophosphataemia. Neutralisation of FGF23 by burosumab increases renal tubular reabsorption of phosphate and the serum concentration of 1, 25 dihydroxy-vitamin D.
What post-market commitments will the sponsor undertake
  • 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

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