US FDA approves first enzyme-blocking antiviral in 20 years

Alicia Farmer
October 28, 2018

Xofluza is the first new type of flu drug approved in two decades. There have already been a handful of deaths as a result of the flu so far in the U.S., and a year ago the flu killed 80,000 individuals.The drug, known generically as baloxavir marboxil but sold under the brand name Xofluza, was invented and is manufactured by the Japanese company Shionogi & Co.

TIME further notes that, in clinical trials, patients who took Xofluza recovered faster than those who were given a placebo. When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of the illness.

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

The drug is approved for patients 12 years of age or older who've had acute, uncomplicated flu symptoms for no more that 48 hours, and it'll be available in the US within the next few weeks. It's meant for anyone over 12-years-old who's been suffering from the flu no more than two days.

"New treatment options for the flu are important".

The New York Times: F.D.A. FDA Commissioner Scott Gottlieb said in the agency's statement announcing the approval.

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Subscribe to Brainstorm Health Daily, our newsletter about the most exciting health innovations. Genentech is committed to helping people who are prescribed XOFLUZA get access to the medicine and will be offering a coupon for all eligible patients. But here's the catch: It only works if the person has had flu symptoms (like fever, muscle aches, and fatigue) for less than 48 hours. XOFLUZA has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

It works about as well as Tamiflu, Roche's older flu treatment, which is also available in cheaper generic versions.

"It's a one-pill, single dose prescription medication", said Lenchus.

Of course, being a medication, Xofluza still has side effects-the most commonly reported ones were diarrhea and bronchitis, according to the FDA. Those who are pregnant, plan to become pregnant, or are breastfeeding should also talk to their doctor before taking Xofluza, since its effects on an unborn baby or infants are unknown.

"The vaccine helps to reduce complications of the flu as well as the intensity of the flu", Glatter said. There was no difference in the recovery time between Xofluza and Tamiflu.

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