One-dose oral medicine provided results similar to proven twice-daily treatment oseltamivir.

Small children who catch the flu are more likely to have complications ranging from breathing problems to pneumonia, some of which can be fatal and many of which lead to hospitalizations –– there are up to one million globally each year. Oseltamivir is one medicine approved in the United States for the treatment of children under age 10 suffering from the flu.

Positive results from a clinical study with Genentech’s antiviral Xofluza (baloxavir marboxil) suggest that there may soon be a second option. While oseltamivir must be given twice daily, Xofluza is a single-dose oral treatment. In the trial, it was found to be well tolerated by children and comparable in performance to oseltamivir, with respect to reducing the duration of flu symptoms, including fever.

Xofluza is approved in the United States for the treatment of acute, uncomplicated influenza in people 12 years of age and older, and the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Xofluza as a one-dose oral treatment for people at high risk of complications from the flu, which it will make a decision on by early November 2019.

Baloxavir marboxil is the first antiviral medication with a novel mechanism of action to be approved by the FDA in 20 years; it is designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication. In addition, Xofluza has been shown in nonclinical studies to be effective against a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1).

Genentech is also investigating the safety and efficacy of Xofluza in children with the flu under the age of one and in severely ill, hospitalized people with the flu in separate clinical studies. It is also exploring the potential use of Xofluza as a means for reducing the transmission of flu in otherwise healthy people.