FDA approves Xofluza, a novel single-dose drug to treat influenza
Today the US Food and Drug Administration (FDA) approved Xofluza (baloxavir marboxil) for the treatment of flu in patients ages 12 years and older who have been symptomatic for no more than 48 hours.
Xofluza is the first novel flu treatment approved by the FDA in nearly 20 years; the FDA approved the neuraminidase inhibitors oseltamivir and zanamivir in 1999.
In September, the New England Journal of Medicine published results of phase 2 and phase 3 trials of the drug, which showed it reduced flu symptoms by 1 day and significantly reduced viral loads. Xofluza is administered orally, in a single dose.
"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option," said FDA Commissioner Scott Gottlieb, MD, in a press release.
Japan's health ministry has already approved the drug, which was developed in that country and manufactured by Shionogi & Co.
Oct 24 FDA press release
Sep 5 CIDRAP News story "New single-dose antiviral cuts flu symptoms, viral loads"
Study: Paid sick leave tied to higher flu vaccination, care for symptoms
An analysis of a survey conducted during the 2009 H1N1 pandemic found that only 61% of working adults reported having paid sick leave (PSL), and those without PSL were less likely to be vaccinated against flu or seek medical care when sick with influenza-like illness (ILI). A team led by scientists with the US Centers for Disease Control and Prevention (CDC) reported its findings in Vaccine.
The investigators based their findings on the 2009 National H1N1 Flu Survey, which sampled households via landline or cell phone in all 50 states and the District of Columbia. Of 70,944 responses, researchers focused on 15,933 adults who were employed full time, completed the survey January 2010 through June 2010, and answered the PSL questions.
During the 2009-10 pandemic, 61% of employed adults had PSL benefits, and being female, younger, Hispanic, less educated, or in farm or blue-collar occupations were associated with reduced likelihood of having PSL. Researchers also found that those without PSL were less likely to be vaccinated against flu or see a doctor when sick with ILI.
They found, however, that workers with PSL benefits who had recently been sick with ILI and sought treatment weren't more likely than their peers without benefits to take 1 day or more off from work. "This finding suggests that many workers may choose to go to work despite being sick or before being fully recovered from sickness regardless of whether or not they have PSL benefits," they wrote.
Oct 22 Vaccine abstract