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Vafseo
Sponsor
ARTGs
Device/Product name
Vafseo
Active Ingredient
Vadadustat
Date of decision
Published
Submission type
New Chemical Entity
ATC codes
B03XA08
Decision
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 | 19 April 2022 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 30 June 2023 |
| Advisory Committee meeting | 3 and 4 August 2023
|
| Registration decision (Outcome) | 25 September 2023
|
| Completion of administrative activities and registration on ARTG | 4 October 2023
|
| Number of working days from submission dossier acceptance to registration decision* | 244 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
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
Film coated tablet
Strength
150 mg, 300 mg and 450 mg
Other ingredients
Tablet:
microcrystalline cellulose, sodium starch glycolate, hypromellose, silicon dioxide and magnesium stearate.
Film-coating:
150 mg tablet: Opadry II White 85F18422
300 mg tablet: Opadry II Yellow 85F12374
450 mg tablet: Opadry II Pink 85F94586
Containers
Blister pack
Pack sizes
28
Routes of administration
Oral
Dosage
Dose initiation
The recommended starting dose is 300 mg once daily. Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently.
Dose titration
When initiating or adjusting therapy, monitor haemoglobin (Hb) levels every two weeks until stable, then monitor at least monthly. Dose adjustment should be done in increments of 150 mg within the range of 150 mg to a maximum recommended daily dose of 600 mg to achieve or maintain Hb levels within 100 to 120 g/L.
When adjusting the dose, consider the patient’s clinical condition; Hb variability; Hb rate of rise and rate of decline; and Vafseo responsiveness. A single Hb excursion may not require a dosing change.
Treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb levels is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting Vafseo.
Monitoring
When initiating or adjusting therapy, monitor Hb levels every two weeks until stable, then monitor at least monthly.
ALT, AST, and bilirubin must be evaluated prior to the initiation of Vafseo, monthly for three months after initiation and as clinically indicated thereafter, see section 4.4 Special warnings and precautions for use.
For further information refer to the Product Information.
Pregnancy category
C
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.
What was approved
Vafseo (vadadustat) was approved for the following therapeutic use:
Vafseo is indicated for the treatment of anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
What is this medicine and how does it work
Vadadustat is an inhibitor of hypoxia-inducible factor prolyl-hydroxylase (HIF-PH), a group of enzymes that degrade a subunit of hypoxia-inducible factor (HIF) in the presence of oxygen under normal physiological conditions. HIF mediates tissue adaption to low oxygen environments through transcriptional regulation of gene expression. Decreased HIF-PH activity with vadadustat leads to increased cellular levels of HIF thereby stimulating endogenous 13 erythropoietin production, increasing iron mobilization and red blood cell production, resulting in a gradual rate of rise in haemoglobin.
What post-market commitments will the sponsor undertake
- Vafseo (vadadustat) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Vafseo 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 Vafseo EU-risk management plan (RMP) (version 2.0, dated 21 February 2023, data lock point 18 August 2021), with Australian specific annex (version 1.3, dated September 2023), included with submission PM-2022-00525-1-6 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 (Rev 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.
More information
The latest Product Information (PI) and Consumer Medicine 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.