FDA Approves Drug That Cuts Flu Symptoms to Only Two Days
FDA Approves Drug That Cuts Flu Symptoms to Only Two Days
Flu Season: FDA Approves New Influenza Treatment
28 October, 2018, 04:13
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.
Xofluza will be marketed outside Japan and Taiwan by Roche, which also makes commonly prescribed flu medication Tamiflu.
In both trials, patients treated with baloxavir marboxil found their symptoms disappeared more quickly compared with patients who took the placebo.
Xofluza is a pill that can reduce severity and shorten duration of flu symptoms after one just dose. "This novel drug provides an important, additional treatment option", said FDA Commissioner Scott Gottlieb, M.D.
The Food and Drug Administration approved the first new antiviral flu treatment with a novel mechanism of action in almost 20 years, it was announced Wednesday.
Xofluza is cleared to treat acute uncomplicated flu in patients 12 years and older who have had flu symptoms for no more than 48 hours.
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Wednesday's approval of Xofluza for people age 12 and older comes ahead of the brunt of this winter's flu season. The FDA has also set a record-breaking pace in generic drug approvals under Gottlieb, who has made rapid clearances a hallmark of his tenure.
Regulators cautioned, however, that antiviral drugs to treat already developed flu symptoms aren't a substitute for vaccination. However, both treatments require that patients see their physicians within the first day or two that they start feeling the characteristic fever chills and sore throat-which may be hard for patients.In Japan, where the drug was approved in February, a single pill costs $43.50; Genentech has provided a coupon for it online for as little as $30 (pdf).The easiest way to prevent the flu is to get a flu shot. But here's the catch: It only works if the person has had flu symptoms (like fever, muscle aches, and fatigue) for less than 48 hours.
Getting your flu shot should be your first line of defense against the virus, but while the vaccine protects against the most common strains of flu, it's still possible to get the illness over the course of the season. However, some patients did develop side effects including diarrhea and bronchitis, per the recent statement.
Then there's the amount of medication you have to take: Xofluza is a one stop shop, while the others takes a little longer.
"Our tools to go after the flu are pretty limited", he said. There was no difference in the recovery time between Xofluza and Tamiflu.
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