Roche’s flu drug Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III Ministone-2 children study.
The study has showed that Xofluza was well tolerated in children with flu. It also demonstrated that Xofluza is comparable to oseltamivir, a proven effective treatment for children with flu.
Roche’s study evaluated the flu drug against an active comparator (oseltamivir) in children aged between one and less than 12 years old with flu.
Xofluza’s safety and efficacy in children with flu under the age of one is also being evaluated in the global phase III Ministine-1 study.
It is a first-in-class and one-dose oral medicine with a novel proposed mechanism of action, which has showed efficacy in a range of influenza viruses.
Ministone-2 is a multicentre, randomised and double-blind study, which assessed 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 confirmed by a rapid influenza diagnostic test and showing influenza-like symptoms.
The company recruited patients in the study in parallel into two cohorts, including patients aged five to less than 12 years and patients aged one to less than five years.
Shionogi & Co had discovered Xofluza, and is being further developed and commercialised across the globe in partnership with Roche.
As per terms of the deal, Roche has worldwide rights to Xofluza excluding Japan and Taiwan, where rights will be retained by Shionogi.
At present, Xofluza is approved in various countries, including Japan, to treat influenza types A and B in children, adolescents and adults. In the US, it is approved to treat acute and uncomplicated influenza in people 12 years of age and older.
The supplemental new drug application (sNDA) was recently approved by the FDA for Xofluza as a one-dose oral treatment for people at high risk of complications from flu.
Roche chief medical officer and global product development head Dr Sandra Horning said:
Children need new medicines for flu because they are at higher risk of developing 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 hospital globally every year.