Shots: The approval is based on P-III BLOCKSTONE study assessing a single dose of Xofluza vs PBO in household members who were living with someone with influenza confirmed by a rapid influenza diagnostic test Results: The proportion of household members aged ≥12yrs. who developed influenza (1% vs 13%), well-tolerated with no new safety signals Xofluza […]Read More
Shots: The EMA’s CHMP has recommended the approval of Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged ≥12yrs. Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged ≥12yrs. The CHMP recommendation is based on the results of the P-III CAPSTONE-1, CAPSTONE-2 and […]Read More
In a recent interview with PharmaShots, Dr. Neil Collinson, the Senior Principal Clinical Development Scientist at Genentech / Roche shares his insights and highlights on Xofluza. Shots: The P-III BLOCKSTONE study demonstrated that the proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza […]Read More
Shots: The approval of expanded indication is based on P-III CAPSTONE-2 study assessing Xofluza (40/80mg) vs oseltamivir (75mg bid for 5days) & PBO in people who met CDC criteria for being at high risk of complications from flu aged ≥12yrs. The P-III CAPSTONE-2 study results: reduction in time to improve flu symptoms compared to PBO […]Read More
Shots: The P-III MINISTONE-2 involves assessing of Xofluza vs oseltamivir in children with influenza infection & showing influenza symptoms aged 1 to <12yrs., resulted in meeting its 1EPs i.e, patients with AEs up to day 29 (46.1% vs 53.4%) and reduction in length of time that the flu virus continued to be released from the […]Read More
Shots: The P-III MINISTONE-2 (NCT03629184) study involves assessing of Xofluza vs Oseltamivir in children with an influenza infection aged b\w 1 to ≤12yrs. confirmed by rapid influenza diagnostic test/ influenza symptoms The P-III MINISTONE-2 study resulted in meeting its 1EPs demonstrating reduction in duration of flu symptoms including fever and is well tolerated in children […]Read More
Shots: The P-III BLOCKSTONE study results involves assessing of Xofluza vs PBO in children & adults diagnosed with influenza, confirmed by rapid influenza diagnostic test in Japan The P-III BLOCKSTONE study results: household members infected with flu (1.9% vs 13.6%); well tolerated; no new signals are observed; conducted by Shionogi Xofluza is oral therapy to […]Read More
Shots: The sNDA application is based on P-III CAPSTONE-2 assessing Xofluza vs placebo & oseltamivir (75 mg) in 2,184 patients with high risk of complications from the influenza including asthma, chronic lung disease, morbid obesity or heart disease, aged > 12yrs. The P-III CAPSTONE-2 study results: reduction in improvement time of symptoms (74.6 hrs. vs […]Read More
Shots: The approval is based on P-III CAPSTONE-1 study assessing Xofluza vs PBO or oseltamivir 75 mg (bid for 5days) in the US & Japan (N=1436) and P-II study in otherwise healthy people with the Flu P-III CAPSTONE-1 study results: (Xofluza vs PBO): reduction in flu symptoms by >1day (54 hrs vs 80 hrs); (Xofluza […]Read More
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