Morning Briefing
Summaries of health policy coverage from major news organizations
New Single-Dose Flu Medication Approved By FDA After Last Year's Vicious Season
The Food and Drug Administration on Wednesday approved a new, single-dose flu medication to treat people 12 and older who have had the flu for no more than 48 hours. Baloxavir, to be sold by Genentech under the brand name Xofluza, is the only single-dose oral medicine approved to treat the flu. It has been shown to significantly reduce the duration of symptoms. It's expected to be available within weeks. (O'Donnell, 10/24)
Xofluza works in a new way, by blocking an enzyme the virus needs to copy itself. So, at least in theory, circulating flu strains resistant to earlier drugs should not have any resistance to it. It has been shown to work against both A and B strains, which circulate each year, and it is expected to work against dangerous bird flus known to occasionally infect humans, such as the A strains of both H5N1 and A H7N9. (McNeil, 10/24)
Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after one just dose. 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. (Johnson, 10/24)
鈥淲ith thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical.鈥 FDA Commissioner Scott Gottlieb said in the agency鈥檚 statement announcing the approval. 鈥淭his novel drug provides an important, additional treatment option.鈥 (Branswell, 10/24)