"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical", he said, adding the caveat that, while "there are several FDA-approved antiviral drugs to treat flu, they're not a substitute for yearly vaccination".
FDA Commissioner Scott Gottlieb hailed the new treatment option while also warning that it shouldn't be considered a replacement for a flu shot given that the influenza season is now officially upon is. Other companies have worked with third-party vendors such as Crossover Health or One Medical to provide similar services.
Wednesday's approval of Xofluza for people age 12 and older comes ahead of the brunt of this winter's flu season.
Each year, flu typically kills about 12,000 to 56,000 Americans and up to 650,000 people worldwide.
The treatment is the first new influenza drug with a novel mechanism of action that the FDA has approved in almost 20 years.
Xofluza side effects were mild - diarrhea, nausea, headaches and bronchitis - and occurred at about the same rate as study participants given Tamiflu or placebo pills.
That was the highest death toll for the disease in at least forty years. Other drugs include Relenza, which is is an inhaled powder, and Tamiflu, which must be taken orally twice a day for five days.
"Having more treatment options that work in different ways to attack the virus is important, because flu viruses can become resistant to antiviral drugs", said Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research said in the FDA's statement.
On Wednesday, the Food and Drug Administration (FDA) inched closer to a record-breaking year of drug approvals, green lighting the first new antiviral flu medicine with a unique action mechanism in almost two decades. Insured patients will be able to buy the drug for as little as $30, while the wholesale cost is slated at $150.
First, the most important similarity: Antiviral medications work best when they're taken within 48 hours of developing flu symptoms. The pill was initially developed by Shionogi of Japan, where it's already approved. There have already been a handful of deaths as a result of the flu so far in the United States, and past year 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. "The severity of last year's flu season underscores the need for new medical options beyond now available antivirals", he explained. While the efficacy of Roche's Xofluza (baloxavir marboxil) is similar to that of Roche's Tamiflu, it will play a role in the armory of drugs against what can be a deadly infection.