Medicine

FDA Approves First-in-Class Flu Drug

FDA Approves First-in-Class Flu Drug

Today, however, the U.S. Food and Drug Administration (FDA) announced that they've approved the drug baloxavir marboxil (Xofluza) to treat influenza.

Genentech says the single-dose treatment will be available in the coming weeks, and while it will cost $150, it may be available through commercial insurance for $30.

"Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, told FOX Business past year the reason for the massive outbreak-which was the worst since the 2009 swine flu pandemic-is because the virus had the dreaded H3N2 strain, which wasn't well-matched" with our current vaccines that were being distributed across the U.S.

Since 2010, the Centers for Disease Control and Prevention estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths.

Each year, more than 10 percent of the US population gets the flu, and it can be very serious resulting in hospitalization or even death. "This novel drug provides an important, additional treatment option", FDA Commissioner Scott Gottlieb said in a statement on the approval of Xofluza.

The two clinical trials evaluated by the FDA for approval-which involved almost 2,000 patients-showed that Xofluza was able to shorten the duration and reduce the severity of flu symptoms when compared to a placebo (in one trial, people on placebo returned to their normal selves within seven days, while it took slightly more than five days for people on Xofluza).

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The antiviral drug helps stop the influenza virus from replicating.

A Japanese pharmaceutical company announced the development of the flu treatment earlier this year.

While the drug can treat the flu, the FDA in approving the drug reminds people that it is not a replacement for the flu vaccine. One of the studies found that patients who took Xofluza within 48 hours of experiencing flu symptoms had their symptoms clear up more quickly, compared with those who took the placebo.

The drug is also to be studied in a phase 3 programme including paediatric patients and severely ill hospitalised patients with influenza. "Those resistant viruses can be transmitted to others..." Extra research is planned to confirm whether taking Xofluza 10 days before exposure to flu can successfully stave off the respiratory infection.

For the first time in two decades, the U.S.

Some experts are concerned it could lead to certain flu types developing antiviral resistance. Side effects include diarrhea, bronchitis, nausea, common cold symptoms and headaches.


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