US health regulators have approved the first new type of flu drug in two decades. Wednesday's approval of Xofluza for people ages 12 and older comes ahead of the brunt of this winter's flu season. Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after just one dose, the AP reports. It was developed by the Roche Group and Shionogi & Co. It works about as well as Tamiflu, Roche's older flu treatment, which is also available in cheaper generic versions. Tamiflu is taken twice daily for five days. Health officials have said an estimated 80,000 Americans died of flu and its complications last winter, the disease's highest death toll in at least four decades. The severe flu season increased demand for Tamiflu and led to spot shortages.
Roche's Genentech unit plans to launch Xofluza within a few weeks; it will cost $150 without insurance. The need for only one dose is an advantage, as patients don't always take all their meds, says Mark Eisner, Genentech's head of development of infectious disease medicines. In company testing on 1,064 people, Xofluza ended coughing, sneezing, and fever, or greatly reduced symptoms, in just over two days on average; a comparison group given Tamiflu fared similarly. While Xofluza didn't work faster than Tamiflu, it did reduce virus levels in patients' noses and throats more quickly. Xofluza side effects were mild—diarrhea, nausea, headaches, and bronchitis—and occurred at about the same rate as study subjects given Tamiflu or placebo pills. Xofluza, also known as baloxavir marboxil, worked against both Type A and B flu strains. (First death of the flu season: an unvaccinated child.)