FDA Okays First New Drug to Fight the Flu in Nearly 20 Years


The U.S. Food and Drug Administration (FDA) has approved baloxavir marboxil (Xofluza) for acute influenza without complications in people 12 and over who’ve had flu symptoms for no more than 48 hours. Antivirals like Xofluza can help alleviate flu symptoms and shorten the duration of flu when taken within two days of becoming sick, but they are not a substitute for vaccination, according to FDA Commissioner Scott Gottlieb, M.D. The Centers for Disease Control and Prevention (CDC) recommends yearly flu vaccines as the primary way to prevent outbreaks.

Xofluza, which is taken orally as a single dose, was tested in two clinical trials involving 1,832 people randomized to receive the medication, another antiviral flu medication, or a placebo (dummy pill). In both trials, flu symptoms resolved more quickly in study participants who received Xofluza compared with placebo and in the second trial, Xofluza was as effective as the other antiviral drug.

Xofluza was granted FDA approval under priority review, an expedited process when the agency determines a medication would provide significant benefits for treating, diagnosing, or preventing a serious health condition. The most common reactions in people taking this drug are diarrhea and bronchitis (inflammation of the airways).

Sourced from: FDA