A Multicenter, Randomized, Double-Blind, Active (Oseltamivir)-Controlled Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients 1 to <12 Years of Age With Influenza-Like Symptoms
Latest Information Update: 22 Aug 2023
At a glance
- Drugs Baloxavir-marboxil (Primary) ; Oseltamivir
- Indications Influenza virus infections
- Focus Adverse reactions; Registrational
- Acronyms MINISTONE-2
- Sponsors Genentech; Roche
- 17 Aug 2023 Results of post hoc analysis evaluating the safety and efficacy of baloxavir versus oseltamivir in children aged 5-11 years with influenza, published in the Pediatric Infectious Disease Journal
- 04 Jul 2023 According to a Shionogi media release, the company has filed for a supplemental new drug application (sNDA) of Xofluza (baloxavir marboxil) in Taiwan for treatment and post-exposure prophylaxis for influenza virus infection for pediatrics aged 5 to under 12 years.
- 11 Aug 2022 According to a Genentech media release, Dr. Pedro Piedra is the investigator of the study