The US Food and Drug Administration (FDA) recently approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
‘This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. 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.
Flu is a contagious respiratory illness caused by influenza viruses. When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and the duration of the illness.
‘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 Centre for Drug Evaluation and Research.
‘Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.’