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Device/Product name
Active Ingredient
Baloxavir marboxil
Date of decision
Submission type
New chemical entity
ATC codes
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 Xofluza 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.

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

Date of entry onto ARTG
Original publication date
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
Film coated tablet
20 mg, 40 mg
Other ingredients

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.

Blister pack
Pack sizes
Routes of administration

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.

Pregnancy category
B3Drugs 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

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.
What is this medicine and how does it work
Baloxavir marboxil is a prodrug that is converted by hydrolysis to its active metabolite, baloxavir, the active form that exerts anti-influenza activity.Baloxavir acts on the cap-dependent endonuclease (CEN), an influenza virus-specific enzyme in the polymerase acidic (PA) subunit of the viral RNA polymerase complex and thereby inhibits the transcription of influenza virus genomes resulting in inhibition of influenza virus replication. The 50% inhibition concentration (IC50) of baloxavir was 1.4 to 3.1 nmol/L for influenza A viruses and 4.5 to 8.9 nmol/L for influenza B viruses in an enzyme inhibition assay. Nonclinical studies demonstrate potent antiviral activity of baloxavir against influenza A and B virus in vitro and in vivo. The antiviral activity of baloxavir against laboratory strains and clinical isolates of influenza A and B viruses was determined in the Madin-Darby Canine Kidney (MDCK) cell culture assay. The median 50% effective concentration (EC50) values of baloxavir were 0.73 nmol/L (n = 31; range: 0.20 to 1.85 nmol/L) for subtype A/H1N1 strains, 0.83 nmol/L (n = 33; range: 0.35 to 2.63 nmol/L) for subtype A/H3N2 strains, and 5.97 nmol/L (n = 30; range: 2.67 to 14.23 nmol/L) for type B strains. In a MDCK cell-based virus titre reduction assay, the 90% effective concentration (EC90) values of baloxavir were in the range of 0.46 to 0.98 nmol/L for subtype A/H1N1 and A/H3N2 viruses, 0.80 to 3.16 nmol/L for avian subtype A/H5N1 and A/H7N9 viruses, and 2.21 to 6.48 nmol/L for type B viruses.Viruses bearing the PA/I38T/M mutation selected in vitro or in clinical studies show reduced susceptibility to baloxavir. Baloxavir is active against neuraminidase inhibitor resistant strains including H274Y in A/H1N1, E119V and R292K in A/H3N2, and R152K and D198E in type B virus, H274Y in A/H5N1, R292K in A/H7N9.The relationship between antiviral activity in cell culture and inhibition of influenza virus replication in humans has not been established.
What post-market commitments will the sponsor undertake
  • 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.

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