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The U.S. Food and Drug Administration (FDA) expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with a person who has the flu, according to press releases Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours. “This expanded indication for Xofluza will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic,” said Debra Birnkrant, MD, Director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Americans will have to be more vigilant than ever as these viruses spread concurrently.”
In addition, Roche, the developer of the product, said it is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children from one to 12 years of age and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population, Roche said. Xofluza’s safety and efficacy for post-flu exposure prevention is supported by one randomized, double-blind, controlled trial in which 607 subjects, 12 years of age and older who were exposed to a person with influenza in their household, received either a single dose of Xofluza or a single dose of a placebo. Of these 607 subjects, 303 received Xofluza and 304 received the placebo. The trial’s 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. Of those who received Xofluza, 1 percent of subjects met these criteria, compared to 13 percent of subjects who received a placebo for the clinical trial.
FDA Press Release (Nov, 23, 2020):
