Individuals treated preventively with Xofluza (baloxavir marboxil; Genentech) were significantly less likely to develop influenza after exposure to an infected household member, according to data from the phase 3 BLOCKSTONE study.
In BLOCKSTONE, participants who were living with someone with an influenza infection were randomized to receive either a single dose of Xofluza or placebo as a preventive measure. The primary endpoint was the proportion of patients who tested positive for the influenza virus and had a fever, and ≥1 respiratory symptom between day 1 and 10.
Results showed that the proportion of participants who became symptomatically ill following infection with influenza was significantly lower in the Xofluza group compared with the placebo group (1.9% vs 13.6%, P <.0001). Regarding safety, the incidence of adverse events was similar for Xofluza (22.2%) and placebo (20.5%). No serious adverse events were reported for Xofluza. Full results will be presented at an upcoming medical meeting.
“This positive phase 3 study adds to robust existing clinical data for Xofluza, and is the first to show that a single treatment with Xofluza reduced the likelihood that people living with an infected household member would develop the flu,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.
Xofluza, a polymerase acidic endonuclease inhibitor, is currently approved for the treatment of acute uncomplicated influenza in patients ≥12 years of age who have been symptomatic for no more than 48 hours. The FDA is currently reviewing the supplemental New Drug Application (sNDA) for Xofluza for the treatment of influenza in patients at high risk of complications. High risk individuals may include patients ≥65 years of age, or those with comorbid conditions (ie, asthma, chronic lung disease, morbid obesity or heart disease). A decision on this indication is expected by November 4, 2019.
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