Tags : Xofluza

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for

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

Roche’s Xofluza (baloxavir marboxil) Receives CHMP’s Recommendation for Approval to

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

ViewPoints Interview: Genentech’s Dr. Neil Collinson Shares Insights on Xofluza

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

Genentech Reports Results of Xofluza (baloxavir marboxil) in P-III MINISTONE-2

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