United States approves new type of flu medicine
United States approves new type of flu medicine
US health regulators UU They have approved the first new type of flu medicine in two decades.
Wednesday's approval of Xofluza for people 12 years of age or older comes before the worst part of this winter's flu season.
Xofluza is a pill that can reduce the severity and shorten the duration of flu symptoms after a single dose. It was developed by the Roche Group and Shionogi & Co.
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It works just as well as Tamiflu, the oldest treatment for Roche's flu, which is also available in cheaper generic versions. Tamiflu is taken twice a day for five days.
Health officials said that approximately 80,000 Americans died of flu and its complications last winter, the highest number of deaths in the disease in at least four decades. The severe flu season increased the demand for Tamiflu and led to a shortage of spots.
Roche's Genentech unit plans to launch Xofluza in a few weeks. It will cost $ 150 without insurance.
The need for a single dose is an advantage, as patients do not always take all their medications, said Dr. Mark Eisner, head of drug development for infectious diseases at Genentech.
Each year, influenza usually kills between 12,000 and 56,000 Americans and up to 650,000 people worldwide.
"With thousands of people who get the flu every year, and many people become seriously ill, having safe and effective treatment alternatives is critical, and this new drug offers an important option for additional treatment," said the Commissioner of Drug Administration and US Food UU., Dr. Scott Gottlieb said in a statement.
In tests of the company in 1,064 people, Xofluza ended with coughing, sneezing and fever, or very reduced symptoms, in little more than two days on average. To a comparison group given Tamiflu was similar. While Xofluza did not work faster than Tamiflu, it did reduce the level of the virus in the patients' nose and throat more quickly.
Additional tests are planned to determine if Xofluza is better than Tamiflu to prevent the spread of flu to other people and to treat patients at high risk of hospitalization and pneumonia, such as people with diabetes or lung disease, pregnant women, young children and the elderly .
"We believe that this can be important for patients, important for public health," said Eisner.
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Side effects of Xofluza were mild (diarrhea, nausea, headaches and bronchitis) and occurred at approximately the same rate as study participants who received Tamiflu or placebo.
Flu treatments generally work best if taken within 48 hours of the onset of symptoms, and health officials encourage vaccination, preferably by the end of October. Relenza inhalers and Rapivab injections are also available to treat the flu.
Xofluza, also known as baloxavir marboxil, worked against strains of influenza type A and B. The pill was initially developed by Shionogi of Japan, where it is already approved. Roche has the rights to market Xofluza everywhere except Japan and Taiwan.
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