HealthDay News — The selective inhibitor of influenza cap-dependent endonuclease, baloxavir marboxil, is superior to placebo for alleviating influenza symptoms, according to a study published in the September 6 issue of the New England Journal of Medicine.
Frederick G. Hayden, MD, from the University of Virginia School of Medicine in Charlottesville, and colleagues conducted 2 randomized trials involving otherwise healthy outpatients with acute uncomplicated influenza. After completion of a dose-ranging trial, a placebo- and oseltamivir-controlled trial of single, weight-based doses of baloxavir (40 or 80mg) was conducted in patients aged 12 to 64 years.
The researchers found that the median time to alleviation of influenza symptoms was 23.4 to 28.2 hours shorter in the baloxavir vs the placebo group in the phase 2 trial (P<.05). In the phase 3 trial, which included 1064 patients, the median time to alleviation of symptoms was 53.7 and 80.2 hours in the baloxavir and placebo groups, respectively (P<.001). The time to symptom alleviation was similar for baloxavir and oseltamivir. Greater reductions in viral load were seen with baloxavir vs placebo or oseltamivir 1 day after initiation of the regimen.
“Single-dose baloxavir was without evident safety concerns, was superior to placebo in alleviating influenza symptoms, and was superior to both oseltamivir and placebo in reducing the viral load one day after initiation of the trial regimen in patients with uncomplicated influenza,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Shionogi, which manufactures baloxavir and funded the study.
An New Drug Application by Genentech for baloxavir marboxil has been granted Priority Review by the Food and Drug Administration (FDA). The Company expect the FDA to make a decision on approval by December 24, 2018.