Published: Sun, October 28, 2018
Health Care | By Oscar Goodwin

FDA Approves New Fast-Acting Flu Drug

FDA Approves New Fast-Acting Flu Drug

Baloxavir is the actual drug, but Xofluza is what it's called, and it's marketed by Genentech Biotechnology company.

Each year, an estimated 3-11 percent of the USA population gets the flu, and it can be very serious, resulting in hospitalization or even death. Last year, 80,000 deaths were attributed to the virus.

"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical", he said, adding the caveat that, while "there are several FDA-approved antiviral drugs to treat flu, they're not a substitute for yearly vaccination".

"This novel drug provides an important, additional treatment option", said U.S. Food and Drug Administration Commissioner Dr. Scott Gottlieb said in a statement.

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Clinical trials began this summer in the United States.

"While the flu vaccine is a crucial first step in preparing for flu season and preventing illness, XOFLUZA is an important new treatment option if you do get sick".

The medication is approved for people over the age of 12.

The antiviral drug helps stop the influenza virus from replicating. "It has to be given early within the first 24 to 48 hours". That's just six shy of the all-time record of 53 new drug approvals in 1996, and it's not even November yet.

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In both trials, Xofluza patients' symptom were alleviated more quickly compared to the placebo. "The best treatment is prevention and that means get your flu shot", she said. XOFLUZA is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. "Those resistant viruses can be transmitted to others..." Those who are pregnant, plan to become pregnant, or are breastfeeding should also talk to their doctor before taking Xofluza, since its effects on an unborn baby or infants are unknown.

"Our tools to go after the flu are pretty limited", he said.

Genentech recently announced that the global Phase III CAPSTONE-2 study assessing the safety and efficacy of XOFLUZA in people at high risk of complications from the flu, as defined by the CDC, met the study's primary objective and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.

"It's a one-pill, single dose prescription medication", said Lenchus.

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The treatment should be available in the coming weeks.

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