Xofluza is approved for people 12 and older who have had flu symptoms for less than 48 hours and have not developed complications. "With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment options is critical".
The Centers for Disease Control and Prevention still recommends patients get vaccinated against seasonal flu. Other companies have worked with third-party vendors such as Crossover Health or One Medical to provide similar services.
The Xofluza approval isn't just a milestone for flu drug development, though-it's a potential landmark for FDA drug approvals at large. Since 2010, the CDC estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths.
"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 top side effects found in the studies were diarrhea and bronchitis, according to the FDA.
Each year, an estimated 3-11 percent of the USA population gets the flu, and it can be very serious, resulting in hospitalization or even death. Tamiflu, for example, requires the patient to take two doses a day for five days. In the US, Xofluza will be manufactured by Genentech, which is owned by Roche, which makes Tamiflu.More news: Facebook launches searchable database revealing United States political ad spending
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Participants were assigned to receive either the drug, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.
First, the most important similarity: Antiviral medications work best when they're taken within 48 hours of developing flu symptoms.
"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, director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research in a statement. However, both treatments require that patients see their physicians within the first day or two that they start feeling the characteristic fever chills and sore throat-which may be hard for patients.In Japan, where the drug was approved in February, a single pill costs $43.50; Genentech has provided a coupon for it online for as little as $30 (pdf).The easiest way to prevent the flu is to get a flu shot.
Xofluza, also known as baloxavir marboxil, worked against both Type A and B flu strains.
Dr. Lenchus said the drug is taken after a person is diagnosed with the flu. Many of us who get the flu may simply wait it out at home, but what you might not know is that drugs to treat the flu (and speed up your recovery time) are available.