Positive Results for Xofluza in Children With the Flu
Genentech announced that a new study showed that 1-dose of Xofluza (baloxavir marboxil) was a well-tolerated and effective potential treatment for influenza in otherwise healthy children aged between 1 and 11 years of age.
This is good news for treating children with the flu.
But, the Centers for Disease Control and Prevention continues to say the ‘best flu prevention is with an approved influenza vaccine.’
This study met its primary endpoint, which evaluated the proportion of patients with adverse events (AEs) or severe AEs up to study day 29, demonstrating results consistent with the safety profile of Xofluza.
In Xofluza-treated participants, 46.1 percent experienced at least one treatment-emergent AE compared to 53.4 percent in the oseltamivir arm.
This means Xofluza is comparable to oseltamivir, a proven effective treatment for children with the flu.
In addition, consistent with data in adults and adolescents, Xofluza reduced the length of time that the flu virus continued to be released from the body by more than 2-days compared with oseltamivir (viral shedding; median time of 24.2 hours versus 75.8 hours, respectively).
Full results of the study were presented as a late-breaking abstract during the OPTIONS X 2019 congress in Singapore on Sunday, September 1, 2019 (Abstract #11756).
“Each year approximately one in three children develop the flu, and their less mature immune systems mean they are slower to fight the infection and more vulnerable to complications,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development, in a press release on September 1, 2019.
About the MINISTONE-2 study
- MINISTONE-2 is a Phase III, multicenter, randomized, double-blind study that evaluated the safety, pharmacokinetics and efficacy of one dose of Xofluza compared with oseltamivir in otherwise healthy children aged one to less than 12 years with an influenza infection and displaying influenza symptoms (temperature of 38°C or over, and one or more respiratory symptoms).
- Participants enrolled in the study were recruited in parallel into two cohorts: patients aged five to less than 12 years and patients aged one to less than five years. Patients in both cohorts were randomly assigned to receive one dose of Xofluza (2 mg/kg for patients under 20 kg or 40 mg for patients 20 kg or over) or oseltamivir twice a day over five days (dosing according to body weight).
- The primary endpoint of the study was the proportion of patients with adverse events or severe adverse events up to study day 29. Secondary endpoints included pharmacokinetics, time to alleviation of influenza signs and symptoms and duration of symptoms, including fever.
- Xofluza is a first-in-class, one-dose oral medicine with a novel proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. Unlike other currently available antiviral treatments, Xofluza is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.
- Xofluza is currently approved in several countries for the treatment of influenza types A and B in children, adolescents and adults, and in the United States (U.S.) for the treatment of acute, uncomplicated influenza in people 12 years of age and older. In addition, a supplemental New Drug Application (sNDA) for Xofluza as a one-dose oral treatment for people at high risk of complications from the flu is under review by the FDA and a decision is expected by November 4, 2019.
- Xofluza is being further studied in a Phase III development program, including children under the age of one (NCT03653364), severely ill, hospitalized people with the flu (NCT03684044), as well as to assess the potential to reduce transmission of the flu from an infected person to healthy people (NCT03969212).
- Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.
- Xofluza is a prescription medicine used to treat the flu (influenza) in people 12 years of age and older who are otherwise healthy, or at high risk of developing influenza-related complications, who have had flu symptoms for no more than 48 hours. It is not known if XOFLUZA is safe and effective in children younger than 12 years of age or weighing less than 88 pounds (40 kg).
Anti-viral flu medications and preventive flu shots are available at most local pharmacies.
Published by Precision Vaccinations.