In the United States created a drug for the treatment of influenza with one pill

A new drug for the treatment of influenza, a single dose of which can reduce the duration of the disease in adolescents and adults, was presented in an actual study published in the prestigious medical publication New England Journal of Medicine.

Фото: Depositphotos

The article presents the results of two multicenter, double-blind, random clinical trials, one of which was conducted by Frederick G. Heyden, a researcher at the University of Virginia School of Medicine. Both studies found that the drug Baloxavir Marboxyl reduced the duration of symptoms of influenza by about one day and quickly rid the body of the virus compared with placebo, writes University of Virginia.

A larger study of the third phase also showed that baloxavir the symptoms were similar to the effects of the five-day course oseltamivirsold under the brand name Tamiflu, but baloxavir there was a significantly greater antiviral capacity. Studies have not revealed significant side effects.

«Baloxavir demonstrates remarkable antiviral activity in uncomplicated influenza, and if approved by the Food and Drug Administration, it will be an important addition to available treatment options for influenza,” Hayden said.

"Insofar as baloxavir has an innovative antiviral effect, it suppresses influenza A and B viruses, including those that can be resistant to currently available drugs. "

Фото: Depositphotos

Results of the study

The first trial was conducted in Japan in the 2016 year and assessed the safety and efficacy of the drug in 389 adults between the ages of 20 and 64 years. Study participants received either the drug or placebo. The average duration of flu symptoms among those who received the drug was shorter hours on 23,4-28,2 than among participants who received a placebo. (Baloxavir, developed by Shionogi pharmaceutical company, has been approved for use in Japan in children and adults).

A second study was conducted in the USA and Japan during the flu season in 2016-17. Baloxavir compared with both placebo and approved drug, oseltamivir, 1 064 healthy study participants aged 12 to 64 have confirmed flu. The average time for flu symptoms to disappear on the 26,5 hour was shorter among those who received baloxavirthan 80,2 hours among those who were given a placebo. how baloxavirAnd oseltamivir showed the same results for the duration of the symptoms, but baloxavir required only one dose compared to the standard five-day regimen oseltamivir.

"Single dose baloxavir was clearly safe, superior to placebo in alleviating flu symptoms, and superior to oseltamivir, and placebo in reducing viral load one day after the start of therapy,” the researchers note.

In both studies, the incidence of adverse events reported by study participants was the same, regardless of whether the participants took a placebo or drugs.

Next Steps

To become available in the United States, baloxavir need to get permission from the Food and Drug Administration. In June, the FDA approved the drug for priority review, and a decision is expected no later than December 24.

The drug was tested for safety and efficacy among influenza patients at high risk of complications last season, but the results of this testing have not yet been officially presented. It is planned to study its effectiveness for hospitalized patients with influenza, probably in combination with other antiviral agents, as well as in preventing the spread of the influenza virus.

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