The flu is one of the most dreaded common illnesses that impacts the entire world. The flu is an acute respiratory illness caused by influenza viruses A or B . Most people who get the flu recover completely in 1 to 2 weeks, but some people develop serious and potentially life-threatening medical complications, such as pneumonia. Much of the illness and death caused by influenza can be prevented by annual influenza vaccination.

Antiviral drugs are prescription medications that may help prevent flu complications or shorten the severity and duration of flu once you have it. There is now a new option to combatting the illness.

The Food and Drugs Administration of America (FDA), approved. Xofluza (baloxavir marboxil), a single-dose, oral prescription drug. Flu sufferers now have a new option for relieving symptoms. The drug was approved on Wednesday. The antiviral is the first new flu treatment approved by the FDA in nearly 20 years, FDA Commissioner Dr. Scott Gottlieb said in a statement.

The green light comes just as this year’s flu season is getting started and following the deaths of an unvaccinated child in Florida and a man in Washington state. The Centers for Disease Control and Prevention estimates that almost 80,000 people died of the flu last season, everyone is concerned about the flu shot around this time of the year and many elect not to get one.

“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 Dr. Scott Gottlieb said in the release.

Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA’s Center for Drug Evaluation and Research, said the release  of a treatment in flu symptoms with antiviral drugs, catching the illness within 48 hours of onset lessens symptoms and shortens the time people feel ill.

Xofluza was given priority review to expedite the approval process so the FDA could review the drug faster before flu season was in full swing. The drug was studied in two randomized controlled clinical trials of 1,832 patients. Participants were given either Xofluza, a placebo or another current antiviral flu treatment.

“While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination,” Gottlieb said. “Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself.”

The pill is intended for patients who are 12 or older and who have had symptoms for no more than 48 hours. When patients with the flu, a respiratory illness, are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of illness, according to the FDA.

Two clinical trials with 1,832 patients proved the safety and efficacy of Xofluza when taken within 48 hours of experiencing flu symptoms, according to the FDA statement. In both experiments, the Xofluza patients’ symptoms eased in a shorter amount of time compared to placebo patients. However, no difference in symptom duration was seen between patients who received Xofluza and those who received another flu drug.

The most common side effects of Xofluza included diarrhea and bronchitis, the government agency reported.

Xofluza was discovered by Japan’s Shionogi & Co., Ltd. and was developed globally by Shionogi and the Roche Group, according to a statement from Roche. The drug was approved in February by the Japanese Ministry of Health, Labour and Welfare for the treatment of influenza types A and B in both adult and pediatric patients. Excluding Japan and Taiwan, Roche now holds worldwide rights to the drug.

Xofluza will be available across the US in the coming weeks, said Andrew Villani, senior manager, corporate relations, at Genentech, the US based distributor of the new drug. “The wholesale acquisition cost for Xofluza is $150, which is at parity with leading antiviral treatments, including Tamiflu.” However, patients with commercial insurance that cover the cost of the drug and use a coupon available on a company website may pay as little as $30, he added.

The US Centers for Disease Control and Prevention recommends getting the flu vaccine by the end of October. A variety of vaccines have been approved for the 2018-19 flu season, including nasal mist and other needleless options. Flu vaccines are widely available, including in doctor’s offices, local pharmacies, some work places and even certain groceries stores.

Important information to note

Do not take XOFLUZA if you are allergic to baloxavir marboxil or any of the ingredients in XOFLUZA.

Before you take XOFLUZA, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if XOFLUZA can harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if XOFLUZA passes into your breast milk 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Talk to your healthcare provider before you receive a live flu vaccine after taking XOFLUZA.

Take XOFLUZA with or without food. Do not take XOFLUZA with dairy products, calcium-fortified beverages, laxatives, antacids, or oral supplements containing iron, zinc, selenium, calcium, or magnesium.

XOFLUZA is not effective in treating infections other than influenza. Other kinds of infections can have symptoms like those of the flu or occur along with flu and may need different kinds of treatment. Tell your healthcare provider if you feel worse or develop new symptoms during or after treatment with XOFLUZA or if your flu symptoms do not start to get better.