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FDA approves new flu-fighting drug

The U.S. Food and Drug Administration has approved the first flu-fighting antiviral in almost two decades, a drug capable of killing the virus in a single dose, federal regulators said Wednesday.

Known as Xofluza, the medication is a pill for people 12 and older with acute, uncomplicated illness. The drug was designed to lessen influenza’s severity while shortening its length. It is the first antiflu drug that works by inhibiting an enzyme that viruses require for replication.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb said in a statement.  

In addition to being effective against a number of seasonal flu strains, the medication demonstrated efficacy against two potentially deadly bird flu variants – H7N9 and H5N1 – that have caused sickness and death elsewhere in the world. Both avian viruses were resistant to Tamiflu, a widely prescribed flu antiviral.

While Gottlieb hailed Xofluza’s approval as the latest weapon in medicine's flu-fighting arsenal, he underscored that vaccination is the mainstay in public health efforts to keep influenza at bay.

Vaccination not only protects individuals but guards communities through herd immunity, Gottlieb said.

Herd immunity protects populations from infection when a large proportion of individuals are vaccinated and not spreading the virus.

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“I am excited that there’s a new drug, but I am reluctant to get too excited until it has been out for a while,” said Dr. Bruce Farber, chief of infectious diseases at both North Shore University Hospital in Manhasset and Long Island Jewish Medical Center in New Hyde Park.

“We should not think of this as a panacea or as a reason not to get vaccinated,” Farber said.

He added that there is good and bad news about Xofluza.

Like Gottlieb, Farber is pleased there is another option, especially in light of growing resistance among flu viruses to Tamiflu, which like Xofluza, is a product of Roche Group. Studies have demonstrated efficacy on par with Tamiflu, Roche’s older antiviral. However, Tamiflu is taken as a two-pill dosage for five days.

The bad news, Farber said, is that there are still unknowns about Xofluza, particularly whether it has efficacy in patients who are suffering from serious flu complications.

The drug arrives at a time when memories are still fresh from last year’s flu season that killed 80,000 people nationwide and put nearly 1 million people in the hospital.

Last year’s death toll was the highest on record in 40 years. On average in the United States, 12,000 to 56,000 people die of flu complications annually. About 650,000 die of influenza each year worldwide.

The medication was tested in 1,064 people prior to FDA approval, according to the study, which was published in the New England Journal of Medicine.

Roche Group developed the drug with Shionogi and Co., in Japan. Xofluza was approved in Japan before being evaluated for approval in the United States.

For patients without insurance, Xofluza’s single-dose treatment will cost about $150, somewhat more than the five-day course of Tamiflu, which costs about $100. However, Tamiflu has several less-costly generic forms.         

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