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International work-sharing initiative - Baloxavir marboxil (Xofluza)

5 March 2020

The Therapeutic Goods Administration (TGA) has approved a new medicine for the treatment of influenza (flu) as part of an international work-sharing initiative.

Baloxavir marboxil (Xofluza™) is indicated for:

the treatment of uncomplicated influenza in patients 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.

Xofluza™ was registered on the Australian Register of Therapeutic Goods (ARTG) following an evaluation under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium's New Active Substance (NAS) work-sharing initiative. This initiative strengthens international partnerships and provides Australians with improved access to the most recent and innovative treatment options.

The work-sharing initiative streamlines the medicine registration process by reducing duplication of evaluation effort. Each participating regulator leads the evaluation of different parts of the submission dossier. However, each regulator makes independent decisions regarding approval (market authorisation) of the medicine.

The TGA, Health Canada and the Swiss Agency for Therapeutic Products (Swissmedic) jointly evaluated the Xofluza™ submission, making it the first time in the initiative where three regulators have work-shared and the first time Australia has work-shared with Swissmedic.

Xofluza™ is the fourth medicine submission evaluated through the work-sharing initiative but the first example of a medicine that is not for the treatment of cancer.

More information on the ACCS NAS work-sharing initiative is available on our website.