Department of Health publishes Public Summary Document for medicine without a published outcome

MAESTrO Database

8 March 2021 - The Department of Health has published a Public Summary Document for mometasone furoate with indacaterol maleate and glycopyrronium bromide (Enerzair Breezhaler).

The PBAC first considered a submission for mometasone furoate with indacaterol maleate and glycopyrronium bromide (Enerzair Breezhaler) in July 2020. The outcome could not be made public in August as the TGA outcome was unknown.

The TGA approved the use of mometasone furoate with indacaterol maleate and glycopyrronium bromide (Enerzair Breezhaler) on 9 October 2020 for "use as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year."

The Public Summary Document states that the initial submission (July 2020) was deferred.  The outcomes from the July 2020 meeting have been updated accordingly.

The Public Summary Document also states that Enerzair Breezhaler was recommended by the PBAC at a later meeting.  The Public Summary Document does not state a date of PBAC reconsideration and recommendation.  There is no record of this outcome under PBAC Outcomes. 

Michael Wonder

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Michael Wonder