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Aquipta
Australian Prescription Medicine Decision Summary
Sponsor
ARTGs
Device/Product name
Aquipta
Active Ingredient
Atogepant
Date of decision
Published
Submission type
New chemical entity
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 Aquipta 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 | 1 August 2022 |
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice | 3 May 2023 |
Advisory Committee meeting | 1 and 2 June 2023 |
Registration decision (Outcome) | 14 November 2023 |
Completion of administrative activities and registration on ARTG | 12 December 2023 |
Number of working days from submission dossier acceptance to registration decision* | 211 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes
Dose forms
Tablet
Strength
10 mg, 30 mg and 60 mg
Containers
Blister pack
Pack sizes
7 (starter pack for 60 mg tablet only) and 28 (for all strengths)
Routes of administration
Oral
Dosage
The recommended dose for Aquipta is 60 mg taken orally once daily with or without food. 30mg taken once daily for episodic migraine prophylaxis or 30 mg taken twice daily for chronic migraine prophylaxis may also be considered for some patients. Tablets should be swallowed whole and should not be split, crushed, or chewed. Dosing modifications for concomitant use of specific drugs are provided in Table 1 of the Product Information.
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. The pregnancy database 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. The pregnancy database 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
Aquipta (atogepant) was approved for the following therapeutic use:
Aquipta is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.
What is this medicine and how does it work
Atogepant is an orally administered, small molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that blocks the binding of the CGRP to the receptor and antagonises CGRP receptor function. CGRP is a neuropeptide that has been associated with migraine pathophysiology. In the trigeminovascular system, CGRP modulates nociceptive signalling and inflammation, and also functions as a vasodilator.
What post-market commitments will the sponsor undertake
- Aquipta (atogepant) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicines Information] for Aquipta 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 Aquipta Core -risk management plan (RMP) (version 1.1, dated January 2023, data lock point 11 October 2022), with Australia specific annex (version 2.0, dated February 2023), included with Submission PM-2022-02486-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
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 [European Union] 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.
- Submission to the TGA long term safety data for use of atogepant in subjects with chronic migraine when available.
Further information
The latest Product Information (PI) and Consumer Medicines 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.