Xofluza
Registration timeline
The following table summarises the key steps and dates for this application.
This application was evaluated as part of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, with work-sharing between TGA, Health Canada and Swissmedic. Each regulator made independent decisions regarding approval (market authorisation) of the new medicine.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 May 2019 |
| First round evaluation completed | 27 September 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 28 October 2019 |
| Second round evaluation completed | 23 December 2019 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 28 November 2019 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 21 February 2020 |
| Completion of administrative activities and registration on ARTG | 21 February 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 161 |
*Statutory timeframe for standard applications is 255 working days
Lactose monohydrate, Croscarmellose sodium, Povidone, Microcrystalline cellulose, Sodium stearylfumarate, Hypromellose, Purified talc, Titanium dioxide.
Each 20 mg tablet contains 77.9 mg of lactose monohydrate and each 40 mg tablet contains 155.8 mg of lactose monohydrate.
A single oral dose of Xofluza should be taken within 48 hours of symptom onset.
Adults and Adolescents (≥ 12 years of age)
The recommended dose of Xofluza depending on body weight is:- 40 kg to < 80 kg: 40 mg.
- ≥ 80 kg: 80 mg
For further information refer to the Product Information.
Xofluza (baloxavir marboxil) was approved for the following therapeutic use:
Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 years of age and older who have been symptomatic for no more than 48 hours and who are:
- otherwise healthy, or
- at high risk of developing influenza complications.
- Provide TGA with the Annual Reports regarding the Update on the Emergence of Resistance, up to December 2023.
- Xofluza (Baloxavir marboxil) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Xofluza 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 Xofluza Core-Risk Management Plan (RMP) (version 2.0, dated 27 March 2019, data lock point 11 March 2019), with Australian Specific Annex (version 1.0, dated 8 April 2019), included with submission PM-2019-01386-1-2, 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 this 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 this 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.
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.