One dose of Xofluza was well-tolerated and demonstrated comparable efficacy to oseltamivir in children aged 1 to younger than 12 years with influenza, according to findings from a phase 3, multicenter, randomized, double-blind study.
In October 2018, the FDA approved Xofluza (baloxavir marboxil, Genetech) for patients aged older than 12 years — the first new influenza treatment in nearly 2 decades.
Sandra Horning, MD, chief medical officer and head of global product development at Genetech, said in a press release that new medications for influenza are needed for children because they are more likely to become infected and develop breathing problems, pneumonia and other complications.
“These flu complications, which in some cases can be fatal, lead to approximately 1 million children aged younger than 5 years being admitted to the hospital globally every year,” Horning said. “As a one-dose oral suspension medicine, Xofluza could potentially provide a convenient treatment option for children with the flu, and we look forward to sharing these data with health authorities around the world.”
In the trial, named MINISTONE-2, researchers compared the safety and efficacy of one dose of baloxavir marboxil with twice-daily oseltamivir for 5 days (dosing according to body weight) in two cohorts of children aged 1 to younger than 5 years and 5 to younger than 12 years. Participants were evaluated for 29 days.
A separate global phase 3 study is currently in progress to assess the safety and efficacy of baloxavir marboxil in children aged younger than 1 year. – by Katherine Bortz
Disclosure: Horning is an employee of Genetech.