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Vyepti
Sponsor
Device/Product name
Vyepti
Active Ingredient
Eptinezumab
Date of decision
Published
Submission type
New biological entity
ATC codes
Not yet assigned
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 Vyepti 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 | 2 June 2020 |
| First round evaluation completed | 17 November 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 21 December 2020 |
| Second round evaluation completed | 10 February 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 1 March 2021 |
| Sponsor's pre-Advisory Committee response | 15 March 2021 |
| Advisory Committee meeting | 8 and 9 April 2021 |
| Registration decision (Outcome) | 9 June 2021 |
| Completion of administrative activities and registration on ARTG | 16 June 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 213 |
*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
Concentrated injection for dilution for infusion
Strength
100 mg/mL
Other ingredients
Histidine, histidine hydrochloride monohydrate, polysorbate 80, sorbitol, water for injections
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous infusion
Dosage
The recommended dosage is 100 mg administered by intravenous infusion every 12 weeks. Some patients may benefit from a dosage of 300 mg administered by intravenous infusion every 12 weeks. The treatment benefit should be assessed 3 to 6 months after initiation of the treatment. The need for dose escalation should be assessed within 12 weeks after initiation of the treatment. The decision to continue with treatment should be made on an individual patient basis, determined prior to each dose.
For further information refer to the Product Information.
Pregnancy category
B1Drugs 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 not shown evidence of an increased occurrence of fetal damage.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
Vyepti (eptinezumab) was approved for the following therapeutic use:
Vyepti is indicated for the preventive treatment of migraine in adults.
What is this medicine and how does it work
Eptinezumab is a humanised immunoglobulin G1 (IgG1) antibody that binds to α- and β- forms of human calcitonin gene-related peptide (CGRP) ligand with low picomolar affinity preventing its activation of the CGRP receptors. Elevated blood concentrations of CGRP have been associated with migraine.Eptinezumab is highly selective and does not bind to any of the related neuropeptides amylin, calcitonin, adrenomedullin and intermedin.
What post-market commitments will the sponsor undertake
- Vyepti (eptinezumab) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Vyepti 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 Vyepti European Union (EU)-Risk Management Plan (RMP) (version 1.1, date 9 February 2021; data lock point 30 November 2020), with Australian specific annex (version 3.0, dated 12 February 2021), included with submission PM-2020-01823-1-1, 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.
- Laboratory testing and compliance with Certified Product Details
All batches of Vyepti 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 http://www.tga.gov.au/ws-labs-index and periodically in testing reports on the TGA website.
- For all injectable products the PI must be included with the product as a package insert.