"XOFLUZA is the first new flu medicine with a novel proposed mechanism of action approved in almost 20 years, and we're excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose", said Dr. Sandra Horning, chief medical officer and head of global product development at Genentech in a statement.
An exceptionally harsh U.S. flu season past year resulted in more than 900,000 people getting hospitalized and more than 80,000 deaths, according to estimates here from the U.S. Centers for Disease Control and Prevention.
There's a new drug on the market to help fight the flu that doctors believe could be a game-changer.
"Although there is no substitute for the flu vaccine, we appreciate the development of any medication that assists in the treatment of influenza", said Dr. Rebekah Gee, secretary of the Louisiana Department of Health.
According to CNN, Xofluza is a single-dose pill available by prescription.
The marketing approval for baloxavir marboxil follows the results of two randomised controlled clinical trials of 1,832 patients where participants received either baloxavir marboxil, a placebo, or another antiviral influenza treatment within 48 hours of experiencing flu symptoms.
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Instead of multiple pills over days, Xofluza can be administered in just one pill.
"Tamiflu is given twice daily for five days, whereas the new drug is a single dose and then you are done", she said. Current treatments - including existing vaccines and antiviral drugs - have limitations as flu viruses are constantly changing and new antiviral medicines are necessary.
Genentech, which will sell Xofluza in the United States, is offering coupons that cut the price to $30 for patients with insurance and to about $90 for those without.
"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. Xofluza side effects were mild and occurred at about the same rate as Tamiflu.
While the flu shot will help keep you from getting the flu in the first place, antiviral drugs can help lessen the duration and severity of the illness. Other important flu prevention steps include frequent hand-washing and avoiding others who are sick.
Dr. Lenchus said the drug is taken after a person is diagnosed with the flu.