FDA Approves New Influenza Drug, Just in Time for Flu Season

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By : Suvarna Sheth

Genentech announced yesterday that the U.S. Food and Drug Administration (FDA) has approved XOFLUZA™ for the treatment of the flu, in patients 12 years of age and older.

XOFLUZA is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication, according to a company press release.

The flu-fighting medication has shown efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains in non-clinical studies.

“XOFLUZA is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, and we’re excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose,” said Dr. Sandra Horning, chief medical officer and head of global product development at Genentech in a statement.

“If patients see their doctors within 48 hours of symptom onset, one dose of XOFLUZA can significantly reduce the duration of flu symptoms,” she added.

The Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths since 2010.

XOFLUZA was approved based on results from the Phase 3 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu, as well as results from a placebo-controlled Phase II study in otherwise healthy people with the flu.

XOFLUZA will be available across the U.S. in the coming weeks.


  1. Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza. 2018, October 24. Business Wire. Retrieved: October 25, 2018, from https://www.businesswire.com/news/home/20181024005745/en/Genentech-Announces-FDA-Approval-XOFLUZA-Baloxavir-Marboxil