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FDA approves first new flu drug in nearly 20 years

(CNN) -- Flu sufferers now have a new option for relieving symptoms. Xofluza (baloxavir marboxil), a single-dose, oral prescription drug, was approved by the US Food and Drug Administration 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.

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"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical," said Gottlieb.

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.

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While Gottlieb welcomed the addition of another drug to treat influenza, he stressed that no treatment is a replacement for the flu vaccine and urged anyone who has not done so to get a flu shot.

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.

The vaccine is imperfect and some people may still get sick even after getting a flu shot. However, those who get flu after receiving vaccine are less likely to require hospitalization and they're less likely to die, according to the CDC.

October 24, 2018


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