First novel, single-dose flu drug approved in US in almost 20 years

The FDA has announced that it has approved the first single-dose flu drug with a novel mechanism of action in nearly two decades. The US regulator authorised Shionogi’s Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza in patients older than 12 years old who have shown symptoms for 48 hours or less.

The decision was based on data derived from two randomised clinical trials of 1,832 patients, demonstrating that Xofluza was quicker to alleviate flu symptoms than placebo, and proved non-inferior to other antiviral flu treatments with regards to speed of alleviation.

The approval follows the drug’s designation under the Priority Review pathway following the flu season of 2017-18, where around 80,000 died from complications relating to the disease.

"This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years," said FDA Commissioner Scott Gottlieb. "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."

However, he added: "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 hospitalisations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks."

Debra Birnkrant, Director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, also remarked: "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. Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs."