US health authorities approve first new type of flu medicine in two decades

TRENTON, New Jersey –

US health regulators have approved the first new type of influenza drug in two decades.

Wednesday's approval of Xofluza for ages 12 and up marks the start of this winter's influenza season.

Xofluza is a medication that can reduce the severity and reduce the duration of flu symptoms after a single dose. It was developed by the group Roche and Shionogi & Co.

It works as well as Tamiflu, the former Roche flu treatment, which is also available in less expensive generic versions. Tamiflu is taken twice a day for five days.

Health officials said that about 80,000 Americans would have died of the flu and its complications last winter, the heaviest toll of the disease for at least four decades. Severe influenza season has increased demand for Tamiflu and leads to shortages.

The Genentech Roche unit plans to launch Xofluza within a few weeks. It will cost you $ 150 without insurance.

The need for a single dose is an advantage because patients do not always take all their medications, said Dr. Mark Eisner, head of infectious drug development at Genentech.

Every year, the flu kills an estimated 12,000 to 56,000 Americans and up to 650,000 people worldwide.

"With thousands of people contracting the flu each year and seriously ill, safe and effective treatment alternatives are essential, and this new drug is an important additional treatment option," said Dr. Scott Gottlieb, Commissioner of the US Food and Drug Administration said in a statement.

In the 1,064-person in-company tests, Xofluza stopped coughing, sneezing, and fever, or significantly reduced symptoms in just over two days on average. A control group receiving Tamiflu achieved similar results. Although Xofluza did not work faster than Tamiflu, it did reduce the level of virus in the nose and throat of patients faster.

Additional tests are planned to determine if Xofluza is better than Tamiflu to prevent the spread of influenza and treat patients at high risk of hospitalization and pneumonia, such as diabetics or lung diseases, pregnant women, young children and the elderly.

"We think this can be important for patients and for public health," said Eisner.

The side effects of Xofluza were mild – diarrhea, nausea, headache, and bronchitis – and occurred at approximately the same rate as participants in the study who received Tamiflu or placebo.

Influenza treatments generally give better results if taken within 48 hours of onset of symptoms, and health officials encourage vaccination, preferably by the end of October. Relenza Inhalers and Rapivab Injections are also available to treat flu.

Xofluza, also known as baloxavir marboxil, works against both influenza A and B strains. The pill was originally developed by Shionogi of Japan, where it is already approved. Roche has the rights to market Xofluza everywhere except Japan and Taiwan.