ย MedicalResearch.com: What are the applicable pediatric and post-exposure indications?
Response: We recentlyย announcedย that the U.S. FDA has accepted a New Drug Application (NDA) as well as two supplemental New Drug Applications (sNDA) for Xofluzaยฎย (baloxavir marboxil). The FDA accepted an NDA for a new formulation of Xofluza as one-dose granules for oral suspension (2 mg/mL), potentially offering a more convenient option for children and those who have difficulty swallowing. In addition, the application seeks approval of Xofluza for the treatment of acute uncomplicated influenza in otherwise healthy children aged one to less than 12 years of age who have been symptomatic for no more than 48 hours.
The FDA also accepted an sNDA for post-exposure prophylaxis of influenza in people one year of age and older for both the oral suspension and currently-available tablet formulation.
MedicalResearch.com: What is the background for and main findings of the underlying studies? How doesย Xofluzaยฎย differ from other drugs for flu treatment or prevention?ย
Response: These filings are based on positive results from two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were both recently presented as late breakers at the 2019 OPTIONS X congress in Singapore.
The miniSTONE-2 study evaluated the safety, pharmacokinetics and efficacy of single-dose, oral suspension Xofluza compared with oseltamivir in otherwise healthy children aged one to less than 12 years of age with influenza. The median time to alleviation of signs and symptoms in influenza-infected participants was 138 hours (95% CI: 117, 163) and 150 hours (95% CI: 115, 166) for those who received Xofluza or oseltamivir, respectively. Xofluza was well tolerated, with no safety signals identified.
BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone who had been diagnosed with influenza. The proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza compared to those treated with placebo (proportion of subjects with influenza virus infection, fever and other flu symptoms in the 10-day observation period: 2% versus 14%, p
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