TRENTON, NJ (AP) – The US health authorities have approved the first new type of influenza drug in two decades.…
TRENTON, NJ (AP) – The US health authorities have approved the first new type of influenza drug in two decades.
Wednesday’s approval of Xofluza for people aged 12 years and older comes before the brown of the winter flu season.
Xofluza is a pill that can reduce the severity and shorten the length of flu symptoms after a single dose. It was developed by Roche Group and Shionogi & Co.
It works as well as Tamiflu, Roche’s older influenza treatment, which is also available in cheaper generic versions. Tamiflu is taken twice a day for five days.
Health officials have said that about 80,000 Americans died of the flu and its complications last winter, the highest deaths of the disease for at least four decades. The severe flu season increased demand for Tamiflu and led to lack of shortage.
Roches Genentech device plans to start Xofluza within a few weeks. It costs $ 1
50 without insurance.
The need for only one dose is an advantage as patients do not always take all their medications, says Dr. Mark Eisner, Genentech’s Chief Development Officer for Communicable Disease Medicine.
Every year, the flu usually kills about 12,000 to 56,000 Americans and up to 650,000 people worldwide.
“With thousands of people who get the flu every year and many people get seriously ill, it’s important to have safe and effective treatment options. An important, extra treatment option,” said the US Food and Drug Administration Commissioner Dr. Scott Gottlieb in a statement.
In company testing of 1,064 people, Xofluza stopped coughing, sneezing and fever or severely reduced symptoms, just over two days on average. A comparative group that gave Tamiflu went the same way. While Xofluza did not function faster than Tamiflu, the level of virus in the patient’s nose and throat rapidly decreased.
Further testing is planned to determine if Xofluza is better than Tamiflu to prevent the spread of flu to others and to treat patients at high risk of hospitalization and pneumonia, such as people with diabetes or lung disease, pregnant women, toddlers and elderly.
“We think this may be important for patients who are important to public health,” says Eisner.
Xofluza side effects were mild – diarrhea, nausea, headache and bronchitis – and occurred approximately as much as study participants receiving Tamiflu or placebo pills.
Influenza treatments generally work best if taken within 48 hours after symptoms start, and healthcare officers encourage vaccination, preferably at the end of October. Relenza inhalers and Rapivab injections are also available for the treatment of flu.
Xofluza, also known as Baloxavirmarboxil, worked against both Type A and B influenza strains. The pellet was initially developed by Shionogi in Japan, where it is already approved. Roche is entitled to market Xofluza everywhere, but Japan and Taiwan.
Follow Linda A. Johnson on Twitter: @ LindaJ_onPharma
Associated Press Health & Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.