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The agency has approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza.
FDA announced on Oct. 24, 2018 that it has approved Xofluza (baloxavir marboxil), from Shionogi & Co., Ltd, for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Xofluza (baloxavir marboxil) is the first new antiviral flu treatment with a novel mechanism to be approved in nearly 20 years, according to FDA.
“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”
The approval follows two randomized controlled clinical trials of 1832 patients who received either Xofluza, a placebo, or another antiviral treatment within 48 hours of experiencing flu symptoms. According to FDA, patients treated with Xofluza had relief from symptoms in a shorter time period compared with patients who received the placebo. A second trial showed symptoms alleviated in the same amount of time as another flu treatment.
“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, MD, in the press release. “While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. Flu season is already well underway, and the US 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.”