Expanded Approval for Genentech Flu Drug

FDA has given expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for patients 12 years of age and older after contact with an individual who has the flu. Xofluza was approved in 2018 in a tablet formulation for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. It is also now available as granules for mixing in water.

Approval for the Xofluza’s post-flu exposure prevention is supported by one randomized trial in 607 subjects. The primary endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day one to day 10, according to FDA. “Of those who received Xofluza, 1% of subjects met these criteria, compared to 13% of subjects who received a placebo for the clinical trial.” Xofluza’s most common side effects include diarrhea, bronchitis, nausea, sinusitis and headache.