Positive phase III results show Xofluza reduces risk of Flu after contact with an infected person by 86 percent.- Genenech/Roche

Genentech, announced that the Phase III BLOCKSTONE study showed preventive treatment with Xofluza (baloxavir marboxil) after exposure to an infected household member significantly reduced the risk of people developing the flu by 86 percent versus placebo. The results show just 1.9 percent of Xofluza-treated household members had the flu compared with 13.6 percent in the placebo-treated group (p<0.0001). this benefit with xofluza remained statistically significant versus placebo regardless of influenza a subtype h1n1: 1.1 percent versus 10.6 percent p="0.0023;" h3: 2.8 percent versus 17.5 percent p><0.0001).>

It was also observed in household contacts who are at high risk of flu-associated complications (2.2 percent versus 15.4 percent, p=0.0435), and children under 12 years of age (4.2 percent versus 15.5 percent, p=0.0339), who are more vulnerable to developing the flu.

Xofluza had a comparable safety profile to placebo, with an overall incidence of adverse events being 22.2 percent for Xofluza and 20.5 percent for placebo. No serious adverse events were reported for Xofluza. Full results of the study were presented as a late-breaking abstract during the OPTIONS X 2019 congress in Singapore on Sunday, September 1, 2019 (Abstract #11718).

The BLOCKSTONE study also demonstrated that even when fewer criteria were applied (proportion of participants with the flu, with fever or one or more respiratory symptoms), there was still a significant 76 percent reduction in the risk of household members developing the flu with Xofluza versus placebo (5.3 percent versus 22.4 percent respectively, p<0.0001). xofluza is the first and only one-dose oral medicine approved to treat the flu in otherwise-healthy patients and the first flu medicine with a novel proposed mechanism of action approved by the fda in nearly 20 years. robust clinical evidence has demonstrated the benefit of xofluza in several populations otherwise-healthy high-risk children and treatment settings symptomatic flu post-exposure prophylaxis.>