We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Tavneos
Sponsor
Device/Product name
Tavneos
Active Ingredient
Avacopan
Date of decision
Published
Submission type
New entity
ATC codes
L04AA59
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 Avacopan 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.
| Description | Date |
|---|---|
| Designation (Orphan) | 26 November 2021
|
Submission dossier accepted and evaluation commenced
| 31 January 2022 |
| Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 1 November 2022 |
| Advisory Committee meeting | 1 and 2 December 2022 |
| Registration decision (Outcome) | 17 January 2023 |
| Completion of administrative activities and registration on ARTG | 31 January 2023 |
| Number of working days from submission dossier acceptance to registration decision* | 202 |
*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
Hard capsule
Strength
10 mg
Other ingredients
Shellac, iron oxide yellow, titanium dioxide, iron oxide red, potassium hydroxide, iron oxide black, PEG-40 hydrogenated castor oil, gelatin, macrogol 4000 and polysorbate 80
Containers
Bottle
Pack sizes
30 and 180
Routes of administration
Oral
Dosage
Treatment should be initiated and monitored by healthcare professionals experienced in the diagnosis and treatment of GPA or MPA.
The recommended dose of Tavneos is 30 mg (3 hard capsules of 10 mg each) taken orally twice daily, morning and evening, with food. Tavneos should be administered in combination with rituximab or cyclophosphamide.
For further information refer to the Product Information.
Pregnancy category
D
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.
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.
What was approved
Tavneos (avacopan) was approved for the following therapeutic use:
Tavneos, in combination with a rituximab or cyclophosphamide based regimen, is indicated for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]).
What is this medicine and how does it work
Avacopan is a selective antagonist of the human complement 5a receptor (C5aR1 or CD88) and competitively inhibits the interaction between C5aR1 and the anaphylatoxin C5a.
The specific and selective blockade of C5aR1 by avacopan reduces the pro-inflammatory effects of C5a, which include neutrophil activation, migration, and adherence to sites of small blood vessel inflammation, vascular endothelial cell retraction and permeability.
Avacopan does not decrease the formation of the membrane attack complex (C5b-9) or terminal complement complex (TCC), which is important in fighting infections with encapsulated bacteria such as Neisseria meningitidis.
The specific and selective blockade of C5aR1 by avacopan reduces the pro-inflammatory effects of C5a, which include neutrophil activation, migration, and adherence to sites of small blood vessel inflammation, vascular endothelial cell retraction and permeability.
Avacopan does not decrease the formation of the membrane attack complex (C5b-9) or terminal complement complex (TCC), which is important in fighting infections with encapsulated bacteria such as Neisseria meningitidis.
What post-market commitments will the sponsor undertake
- Tavneos (avacopan) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Tavneos 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 Tavneos EU [European Union]-risk management plan (RMP) (version 1.6, dated 17 January 2022; data lock point 24 March 2020), with Australia specific annex (version 1, dated 1 December 2020), included with Submission PM-2021-05913-1-3, 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 (revision 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found at the Australian Register of Therapeutic Goods (ARTG) search.
Australian Public Assessment Reports (AusPARs) can be found at the AusPAR search.
The latest news and updates regarding therapeutic goods regulation can be found at the TGA news.