FDA Approves First Flu Antiviral in Almost Two Decades

The U.S. Food & Drug Administration (FDA) has approved baloxavir marboxil to treat acute uncomplicated influenza in patients aged 12 years and older who have had symptoms for no more than 48 hours. It is the first antiviral flu therapy approved by the FDA in nearly 20 years. 

Baloxavir marboxil, marketed as Xofluza, received priority review from the FDA. It was tested in two randomized controlled clinical trials that included 1,832 total patients who received baloxavir marboxil, a placebo, or another antiviral flu treatment within 48 hours of initial symptoms. In both trials, baloxavir marboxil alleviated symptoms faster than placebo. 

Results from the second trial were published in the New England Journal of Medicine in September. In this trial, patients received weight-based doses of baloxavir marboxil (40 or 80 mg), 75 mg doses of oseltamivir twice a day for five days, or placebo. Median time to symptom relief in the baloxavir marboxil groups was 23.4 to 28.2 hours shorter than in the placebo group (< 0.05). Among patients with influenza A (H3N2) infection, median symptom alleviation time was 53.7 hours (95% confidence interval [CI], 49.5 to 58.5) with baloxavir marboxil, compared with 80.2 hours (95% CI, 72.6 to 87.1) with placebo (P < 0.001). Viral load reduction one day after treatment was greater in baloxavir marboxil patients than those receiving placebo or oseltamivir. There was no significant difference in median time to alleviation of symptoms between the baloxavir marboxil and oseltamivir groups. Adverse events occurred in 20.7% of baloxavir marboxil patients, 24.6% of placebo patients, and 24.8% of oseltamivir patients. 

Diarrhea and bronchitis were the most common adverse effects associated with baloxavir marboxil, according to the FDA. 

“With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. 

The commissioner also stressed the importance of getting a flu shot. 

“While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination,” he said. “Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.” 

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Sources: NEJMFDA, Medscape