FDA Approves First New Influenza Drug in 20 Years

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"XOFLUZA is the first new flu medicine with a novel proposed mechanism of action approved in almost 20 years, and we're excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose", said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment options is critical".

Villani told us that Xofluza has a mechanism of action that blocks an enzyme within the flu virus.

Xofluza is not a substitute for the annual flu shot.

For the first time in nearly two decades, the US Food and Drug Administration (FDA) approved a drug to combat the flu in people over 12 years old after symptoms have started.The approval, announced on Wednesday (Oct. 24), comes just in time for the ramping up of flu season in the northern hemisphere. However, some patients did develop side effects including diarrhea and bronchitis, per the recent statement.

"Tamiflu is given twice daily for five days, whereas the new drug is a single dose and then you are done", she said.

"This works by inhibiting, by preventing the replication, the duplication of the virus, so this is very different than the way the Tamiflu works", said Lenchus, "so that's what makes this relatively groundbreaking".

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The pill will cost about $150 for patients without health insurance.

As the flu season approaches in the Northern Hemisphere, news of a drug that can shorten the duration of influenza symptoms, even by a matter of a day or two, may be warmly welcomed.

The drug, Japanese pharmaceutical company Shionogi's and Roche arm Genentech's Xofluza (or baloxavir marboxil), is different from existing medication in the sense that it attacks the virus through a different method.

The FDA approved the new flu medication under an expedited review process used when it determines the drug "would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition". In February 2018, it was approved in Japan for the treatment of influenza types A and B. You will need a prescription to get it.

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.

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