FDA Approves Baloxavir Marboxil for High-Risk Flu Patients

October 21, 2019

First approved in 2018 for patients 12 years of age and older.

The FDA has approved a supplemental new drug application for baloxavir marboxil (Xofluza, Genentech) for patients who are at a high risk of developing complications from the flu. 

Baloxavir marboxil is a polymerase acidic endonuclease inhibitor previously approved in 2018 for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for no longer than 48 hours. 

“With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications,” said Levi Garraway, MD, PhD in a statement. “People with chronic conditions such as asthma, heart disease, and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease.”

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The supplemental approval stems from the results of a Capstone 2 trial-a Phase III, randomized, double-blind study that evaluated single dose baloxavir marboxil compared to placebo and oseltamivir.  

Baloxavir marboxil was shown to significantly reduce flu symptom improvement time, showed similar efficacy results to oseltamivir, and improved the median time to improvement compared to placebo in subjects with type b virus. 

Adverse events reported throughout the study include diarrhea, bronchitis, nausea, sinusitis, and headache. No new safety signals were identified. 

Baloxavir marboxil is contraindicated in patients with a known hypersensitivity to the active ingredient or any of the product’s ingredients. 

Baloxavir marboxil has not been shown to prevent bacterial infections that may stem from flu complications.