Influenza

FDA Approves First Single-Dose Option for Influenza Prevention

Xofluza (baloxavir marboxil) is now approved by the US Food and Drug Administration for post-exposure prevention of influenza in individuals 12 years of age and older who have been exposed to someone with the flu.

“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech USA, Inc.1

Xofluza was originally approved in 2018 for the treatment of patients with influenza who were 12 years of age and older who were symptomatic for no more than 48 hours.

The safety and effectiveness of Xofluza in this population was examined in a randomized, double-blind, controlled trial including 607 subjects who received either a single dose of Xofluza (n=303) or a placebo (n=304). All participants were aged 12 years or older and were exposed to influenza from someone in their household.

Overall, only 1% of patients who received Xofluza developed influenza compared with 13% of those in the placebo group.

Diarrhea, bronchitis, nausea, sinusitis, and headache were reported. The FDA does not recommend Xofluza for individuals with a known hypersensitivity reaction as hypersensitivity, including anaphylaxis, can occur. The drug should not be taken with dairy products, calcium-fortified beverage, laxatives, antacids, or oral supplements containing calcium, iron, magnesium, selenium, aluminum, or zinc.

 

—Leigh Precopio

 

Reference:

  1. Genentech announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person. News release. Gene. November 23, 2020. Accessed November 24, 2020. https://www.gene.com/media/press-releases/14885/2020-11-23/genentech-announces-fda-approval-of-xofl
  2. FDA expands approval of influenza treatment to post-exposure prevention. News release. US Food and Drug Administration. November 23, 2020. Accessed November 24, 2020. https://www.fda.gov/news-events/press-announcements/fda-expands-approval-influenza-treatment-post-exposure-prevention