Genentech has announced the MINISTONE-2 study, which examined the safety and efficacy of baloxavir marboxil (Xofluza) in patients aged 1 to 12 with the flu, has returned positive results.
Genentech has announced that the MINISTONE-2 study, which examined the efficacy and safety of one-dose baloxavir marboxil (Xofluza) in children with the flu, has demonstrated positive results.
In a press release, the company said baloxavir marboxil was well-tolerated and comparable to oseltamivir in reducing duration of flu symptoms, including fever, in children between the ages of 1 and less than 12 years old with the flu.
“Children need new medicines for the flu because they are at higher risk of developing the flu and more likely to have complications such as breathing problems and pneumonia. These flu complications, which in some cases can be fatal, lead to approximately one million children under five being admitted to the hospital globally every year,” said Sandra Horning, MD, chief medical officer and head of global product development at Genentech.
MINISTONE-2 is a multicenter, randomized, double-blind phase 3 trial that sought to evaluate that safety pharmacokinetics and efficacy of one-dose of baloxavir marboxil compared with oseltamivir in children aged between 1 and 12 with an influenza infection. Participants were enrolled into 2 groups based upon age. The first group was children between the ages of 5 and 12 and the second was made up of children between the age of 1 and less than 5.
The primary endpoint of the study was the proportion of patients with adverse events or severe advents up to study day 29. Secondary endpoints include pharmacokinetics, time to alleviation of influenza signs and symptoms, and duration of symptoms. The full results will be presented at an upcoming medical meeting.
An FDA decision on a supplemental New Drug Application for baloxavir marboxil for the treatment of people at high risk of complications from the flu is due by Nov. 4, 2019. Baloxavir marboxil is already FDA-approved for the treatment of acute, uncomplicated influenza in patients 12 and older.
An additional phase 3 study is examining the safety and efficacy of baloxavir marboxil are currently underway — MINISTONE-1 is evaluating baloxavir marboxil in children under the age of 1 with the flu.
“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,” Horning said.