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Nuceiva
Sponsor
Device/Product name
Nuceiva
Active Ingredient
PrabotulinumtoxinA
Date of decision
Published
Submission type
New biological entity
ATC codes
M03AX01
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 Nuceiva 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 |
|---|---|
|
Submission dossier accepted and first round evaluation commenced |
31 January 2022 |
|
First round evaluation completed |
26 July 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
27 July 2022 |
|
Second round evaluation completed |
28 October 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
3 November 2022 |
|
Sponsor’s pre-Advisory Committee response |
17 November 2022 |
|
Advisory Committee meeting |
1 and 2 December 2022 |
|
Registration decision (Outcome) |
13 January 2023 |
|
Completion of administrative activities and registration on ARTG |
25 January 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
198 |
*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
Powder for solution for injection
Strength
100 U
Other ingredients
Albumin, sodium chloride
Containers
Vial
Pack sizes
One
Routes of administration
Intramuscular
Dosage
Nuceiva should only be administered by physicians with appropriate qualifications and expertise in the treatment of glabellar lines and the use of required equipment.
Once reconstituted, Nuceiva should only be used to treat a single patient, during a single session.
The units of biological activity of Nuceiva (prabotulinumtoxinA) are specific to the preparation and assay method utilized.
Botulinum toxin units are not interchangeable from one product to another. Doses recommended are different from other botulinum toxin preparations.
For further information refer to the Product Information.
Pregnancy category
B3
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.
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.
What was approved
Nuceiva (prabotulinumtoxinA)) was approved for the following therapeutic use:
Nuceiva is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.
What is this medicine and how does it work
Botulinum toxin type A (Clostridium botulinum neurotoxin) blocks peripheral acetylcholine release at presynaptic cholinergic nerve terminals by cleaving synaptosomal-associated protein, 25kDa (SNAP-25), a protein integral to the docking and release of acetylcholine from vesicles situated within the nerve terminals.
After injection, there is an initial high-affinity binding of toxin to specific cell surface receptors on cholinergic nerve terminals. Bound toxin is then internalised by endocytosis, and the catalytic light chain is translocated across the vesicular membrane into the cytosol where it cleaves SNAP-25. Progressive inhibition of acetylcholine release follows and clinical signs usually manifest within 2 to 3 days.
Recovery after intramuscular injection takes place normally within 12 weeks.
After injection, there is an initial high-affinity binding of toxin to specific cell surface receptors on cholinergic nerve terminals. Bound toxin is then internalised by endocytosis, and the catalytic light chain is translocated across the vesicular membrane into the cytosol where it cleaves SNAP-25. Progressive inhibition of acetylcholine release follows and clinical signs usually manifest within 2 to 3 days.
Recovery after intramuscular injection takes place normally within 12 weeks.
What post-market commitments will the sponsor undertake
- Nuceiva (prabotulinumtoxinA) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Nuceiva 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 Nuceiva EU [European Union]-risk management plan (RMP) (version 3.1, dated 4 February 2021, data lock point 27 March 2017), with Australia specific annex (version 1.1, dated 19 October 2021), included with Submission PM-2021-05441-1-1, to be revised to the satisfaction of the TGA, and any subsequent revisions, 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.
- For all injectable products the Product Information must be included with the product as a package insert.