Norgine has obtained the licence for the medicine from Italian Alfa Wassermann SpA.
The positive stance was adopted following positive results from a pivotal six-month randomised, double-blind, placebo-controlled trial of the drug. Data showed that twice-daily Xifaxan 550 mg with or without lactulose reduced by 58% the risk of breakthrough episodes of overt HE over six months versus placebo with or without lactulose. In addition, the medicine decreased by 50% the risk of hospitalisations caused by HE over six months.
The PBAC also deemed Xifaxan 550 to be a cost-efficient treatment option.
The drug is currently being reviewed by UK's National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) and their decisions are expected in the second half of the year.
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