Nurtec ODT
Registration timeline
The following table summarises the key steps and dates for this comparable overseas regulator approach B (COR-B) application.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced
|
7 September 2022
|
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
28 February 2023
|
|
Advisory Committee meeting |
30 and 31 March 2023
|
|
Registration decision (Outcome) |
17 July 2023
|
|
Completion of administrative activities and registration on ARTG |
27 July 2023
|
|
Number of working days from submission dossier acceptance to registration decision* |
159
|
* The COR-B process has a 175 working day evaluation and decision timeframe.
Mint flavour, gelatin, mannitol, sucralose
Acute treatment of migraine
The recommended dose is 75 mg rimegepant orally disintegrating tablet, as needed. The maximum dose in a 24-hour period is 75 mg.
Prophylaxis of migraine
The recommended dose is 75 mg rimegepant every other day. If also requiring rimegepant for the acute treatment of migraine, do not exceed a total dose of 75 mg rimegepant in a 24 hour period.
Nurtec ODT can be taken with or without meals.
For further information refer to the Product Information
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 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.
Nurtec ODT (rimegepant (as sulfate)) was approved for the following therapeutic use:
Nurtec ODT is indicated for:
• acute treatment of migraine with or without aura in adults;
• prophylactic treatment of episodic migraine in adults who have at least 4 migraine attacks per month.
Multiple lines of clinical evidence point to a role for CGRP in migraine pathophysiology: 1) serum levels of CGRP are elevated during migraine; 2) treatment with anti-migraine drugs returns CGRP levels to normal coincident with pain relief and 3) intravenous (IV) CGRP infusion produces lasting pain in non-migraineurs and migraineurs.
- Nurtec ODT (rimegepant [as sulfate]) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Nurtec ODT 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 Nurtec ODT EU [European Union]-risk management plan (RMP) (version 1.0 dated 17 May 2022, DLP [data lock point] 3 September 2021), with Australia specific annex (version 1.1, dated 28 June 2023), included with Submission PM-2022-02939-1-1, 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).
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. Each report must have been prepared within ninety calendar days of the data lock point for that report.
Further information
The latest Product Information (PI) and Consumer Medicines 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.