FDA Approves First New Flu Treatment In 20 Years

This week, the FDA approved a new influenza treatment for the first time in the past two decades. Created by Roche Pharmaceuticals, Xofluza (baloxavir marboxil) is a single dose oral medication intended for patients of at least age 12. The medication is to be taken in the first two days after appearance of symptoms such as fever, sniffles, and aches.

Roche claims that this Xofluza has utilizes a unique mechanism that inhibits polymerase acidic endomuclease, an integral enzyme to flu virus replication. The company’s chief medical officer and head of global product development, Sandra Horning, expressed excitement about achieving the first FDA approval of a flu medication in 20 years. She adds that Roche takes pride in offering a convenient option for flu treatment that yields symptom improvement within one day.

“If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms,” said Horning in a statement.

Xofluza was tested via two randomized controlled clinical trials, including 1,832 patients who were assigned to either receive Xofluza, placebo, or other antiviral flu treatment within two days of symptom onset. Both trials found that those treated with Xofluza experienced symptom alleviation faster than those who took the placebo. The second trial found that those who used Xofluza overcame symptoms just as fast as those who took other flu medication, making this new and convenient treatment option an approval-worthy medication. In fact, the results from these trials were significant enough that the FDA granted Xofluza Priority Review, which fast tracks the approval process for drugs that may significantly improve effectiveness of treating serious conditions.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D.

Gottlieb went on to emphasize that citizens should still receive seasonal flu vaccinations, being that vaccines are the most effective first-line preventative measure, whereas medications like Xofluza are designed to alleviate symptoms in those who have already contracted the flu.

The oral medication will be sold at $150 per pill, as per a spokeswomen for Genentech, the company that will be selling Xofluza in the US. Genentech will also be offering coupons that decrease this price to $30 a pill for those with  health insurance, and $90 for the uninsured.

The pill will cost $150, according to a spokeswoman for Genentech, which will sell Xofluza in this country. Genentech will offer coupons that lower the price to $30 for patients with health insurance and to about $90 for the uninsured.

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Sources: BioSpace, FDA, NYTimes