Shionogi and Roche Get FDA Approval for First New Flu Drug in Nearly 20 Years

According to the CDC, between 5% and 20% of the US population gets the flu in an average year, resulting typically in tens of thousands of hospitalizations and thousands of deaths. An estimated $10.4 billion per year in direct medical expenses and an additional $16.3 billion in lost earnings are incurred annually. While the CDC hasn’t yet released estimates on the total number of hospitalizations from this past flu season, the Influenza Hospitalization Surveillance Network (FluSurv-NET), which only covers about 9% of the US population, showed 30,453 reported laboratory-confirmed flu-related hospitalizations from October 1, 2017, through April 28, 2018. People 65 years and older accounted for approximately 58% of reported influenza-associated hospitalizations.

Vaccinations remain the primary means of preventing the flu. During the 2016–2017 flu season, the CDC estimates that flu vaccines prevented 5.3 million illnesses, 2.6 million medical visits, and 85,000 hospitalizations. Most critically, the flu vaccine has been shown to reduce the risk of flu death in children.

Yesterday the FDA approved the first new antiviral flu treatment since the 1999 approval of Roche’s RHHBY Tamiflu. Xofluza (baloxavir marboxil), which was discovered by Shionogi SGIOY and further developed by Roche, was approved by the FDA on Wednesday 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. Shionogi has commercial rights in Japan, where it was approved in February 2018 by the Japanese Ministry of Health, and Taiwan, while Roche holds rights in the rest of the world including the US.

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. 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 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.

–Scott Gottlieb, MD, Commissioner, FDA

Source: CBS News

The FDA approved Xofluza under its Priority Review program based on Phase 3 results which were recently published in the September 6, 2018, issue of the New England Journal of Medicine. Xofluza significantly reduced the duration of flu symptoms by more than one day vs placebo. Results from a separate study showed that median time of Xofluza improvement was more than 29 hours faster than with Tamiflu in people at high risk of serious complications from the flu.

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.

-Debra Birnkrant, MD, director of the Division of Antiviral Products, FDA’s Center for Drug Evaluation and Research.

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