Roche (OTCQX:RHHBY) announces positive results from a Phase 3 clinical trial, MINISTONE-2, evaluating a single dose of an oral suspension formulation of Xofluza (baloxavir marboxil) for the treatment of influenza in otherwise healthy children aged one to less than 12 years old. The data were presented at the OPTIONS X congress in Singapore.
The study met the primary endpoint of a statistically significant proportion of participants with adverse events (AEs) or severe AEs up to day 29, demonstrating a safety profile consistent with the tablet formulation. Efficacy was comparable to Tamiflu (oseltamivir phosphate). Specifically, 46.1% of children receiving oral suspension Xofluza experienced at least one treatment-emergent AE versus 53.4% in the oseltamivir arm.
Xofluza reduced viral shedding (the period when the virus is actively reproducing) by more than two days compared to oseltamivir (median of 24.2 hours vs. median of 75.8 hours).
Key secondary endpoints were also met.
The FDA approved the tablet formulation of Xofluza in October 2018 for patients at least 12 years old. It was discovered by Shionogi (OTCPK:SGIOY). Roche owns global rights except Japan and Taiwan.
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