FDA OKs Xofluza, First New Flu Antiviral in Nearly 20 Years

The US Food and Drug Administration (FDA) has approved baloxavir marboxil tablets (Xofluza, Shionogi) for the treatment of acute uncomplicated influenza in people age 12 years and older who have been symptomatic for no more than 48 hours.

"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," FDA Commissioner Scott Gottlieb, MD, said in a news release.

Unlike neuraminidase inhibitors, such as oseltamivir (Tamiflu, Genentech), which inhibit the action of neuraminidase (an enzyme that frees viruses from the infected cells' surface), baloxavir marboxil prevents replication by inhibiting cap-dependent endonuclease activity of the viral polymerase.

As previously reported by Medscape Medical News, a single oral dose of baloxavir marboxil significantly reduced the duration of flu symptoms, duration of fever, length of time of viral shedding, and levels of virus in the nose and throat compared with placebo or oseltamivir among otherwise healthy people with the flu in two randomized controlled trials involving over 1800 patients. The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

The findings were published last month in the New England Journal of Medicine.

Xofluza was granted priority review by the FDA. Japan's health ministry approved baloxavir marboxil earlier this year.

Gottlieb noted that although there are several FDA-approved antiviral drugs to treat flu, "they're not a substitute for yearly vaccination," which is the primary means of preventing and controlling flu outbreaks.

Seasonal flu activity often begins as early as October and November and can continue to occur as late as May. Flu activity most commonly peaks in the United States between December and February. The US Centers for Disease Control and Prevention recommends that everyone 6 months and older get vaccinated before the end of October.

Several patients including one child have already died from influenza this flu season, as reported by Medscape Medical News. A child in Florida became the first pediatric influenza fatality this season, according to the Florida Department of Health.



Dr. Marc Armstrong|  Emergency Medicine
Same issue when oseltamivir...reduces by how much? When tamiflu came out they were quite vague. It turned out to reduce course by less than 24hrs, and if I remember correctly, it was also $150 a pop...

Dr. sudhakar kamat| Pulmonary Medicine
noexpirence with this drug;tamiflue works in mild cases-not as well in severe

Dr. greg castello|  Family Medicine
I have had it with drugs starting with the letter X. It's not cleaver, nor pronouncable.

Dr. GREGORY FULLER|  Family Medicine
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.


T. Braun|  Pharmacist
Taking a 10 cent pill daily of 5,000 iu's of Vitamin D will reduce the risk of the flu.

but won't line the pockets of the manufacturer of this new FDA approved drug.

Jacob Gise|  Registered Nurse (RN)
@T. Braun This would be about as effective and well studied as praying to not get the flu.

Dr. Thomas Duncan|  Family Medicine
@Jacob Gise @T. Braun Praying would cost $3 less per month.  Double plus good

Dr. Joshua Gutttman|  Emergency Medicine 4 days ago
Praying is expensive. Try joining a synagogue ;)

Steven Halstead|  Pharmacist
Pharmacists would do well to promote the vaccines- not unproven hopeful aids that line their pockets.

A retired pharmacist.

Dr. AUGUSTINE AKALONU|  Pediatrics, General
What is the rationale for approving a Flu medication that is intended only for people 12 years and up, when younger children are most likely to die from the illness?

Jacob Gise|  Registered Nurse (RN)
@Dr. AUGUSTINE AKALONU ...because of the fast track nature of drug approval. Might take more time to study results in children.


Steven Halstead|  Pharmacist
Excuse me but I believe most pediatric deaths are in those 6 months and younger for whom there is no approved vaccine. Get those over 6 months old and especially the elderly vaccinated and we won't need these antiviral meds. Vaccines are cheaper, more effective and most insurance companies cover the full cost.


Dr. James Toffolo|  Family Medicine
Unfortunately "within the 48 hours of onset" most patients won't have access to a provider in our constipated medical system. Solution: allow pharmacists to distribute/sell and notify PCP via email.

Dr. Mary Inwood|  Internal Medicine
Do you not have a way for patients to reach you or a covering physician on weekends? I instruct my patients to call with flu symptoms (described in detail) within 48 hours, EVEN ON WEEKENDS. If they have appropriate symptoms, I call in rx. Maybe have to do this once or twice a season. We don't want active flu pts in our waiting room anyway!

Jacob Gise|  Registered Nurse (RN)
@Dr. James Toffolo Heard of telemedicine? Slippery slope allowing pharmacists that latitude.

kevin dansby|  Physician Assistant
Won't have access??? Where are you? We have urgent care on every corner.

Dr. Tamerut Adams|  Internal Medicine
Interesting MOA...will see how it helps my present patients!

Dr. Noel Graham|  Pediatrics, General
Over/Under on price?  I'd say $400 for the one pill.

Mark Canevari|  Pharmacist
It shouldn't be that much, maybe 50-150 per pill. However, that is already ridiculous and can always change.

Andrew Kennedy|  Pharmacist
For a novel drug to treat a high profile indication, I'm thinking $400 is low balling it. You don't give drug companies enough credit. It's worth at least $650 for a whole course.


Dr. Thomas Duncan|  Family Medicine
@Andrew Kennedy depends entirely on whether it really works in the real

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