EMA Panel Backs Xofluza for Influenza, Post-Exposure Prophylaxis

Megan Brooks

November 16, 2020

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended approval of the antiviral baloxavir marboxil (Xofluza, Roche) for treatment and post-exposure prophylaxis of uncomplicated influenza in people aged 12 years and older.

The European Medicines Agency (EMA) panel noted that Xofluza has been shown to reduce the duration of influenza-related symptoms in healthy individuals and those at high risk of influenza-related complications and reduce infections when given as post-exposure prophylaxis.

No major common side effects emerged in clinical trials. Hypersensitivity reactions that have been observed in the post-marketing setting include reports of anaphylaxis and less severe hypersensitivity reactions such as urticaria and angioedema.

Xofluza will be available as 20-mg and 40-mg film-coated tablets, according to an EMA news release.

Detailed recommendations for the use of Xofluza will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

The US Food and Drug Administration (FDA) first approved baloxavir marboxil in 2018 for the treatment of acute uncomplicated influenza in people aged 12 years or older who have been symptomatic for no more than 48 hours, as reported by Medscape Medical News.

The FDA has since expanded the indication to include people at high risk of developing influenza-related complications, such as those with asthma, chronic lung disease, diabetes, heart disease, or morbid obesity, as well as adults aged 65 years or older.

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