FDA Approves First New Flu Medication in 20 Years: What to Know


"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 Dr. Debra Birnkrant, FDA director of the Division of Antiviral Products.

"If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms", said Shionogi in a statement on the approval.

Since 2010, the Centers for Disease Control and Prevention 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.

US approval of the first novel anti-flu pill in two decades has doctors cautiously optimistic about a simpler treatment for a virus that killed nearly 200 American children last season. It was developed by the Japanese pharmaceutical Shionogi & Co., Ltd., in collaboration with the Swiss-based pharmaceutical Roche AG.

The two clinical trials evaluated by the FDA for approval-which involved almost 2,000 patients-showed that Xofluza was able to shorten the duration and reduce the severity of flu symptoms when compared to a placebo (in one trial, people on placebo returned to their normal selves within seven days, while it took slightly more than five days for people on Xofluza).

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

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Population-aging and the demand for flu immunizations, treatments and diagnoses will help push up the global influenza market 3 percent a year to reach $6.5 billion by 2022, BCC Research estimated in April. In the second trial, the time to symptom relief was the same for patients who took Xofluza as those who took the other antiviral flu treatment, according to the FDA.

On Wednesday, the FDA approved a new drug to treat the flu just in time for flu season. Testing shows that the treatment is extremely effective against a wide range of influenza viruses. But the trial data also suggested baloxavir may have an advantage in patients with influenza B viral infection.

It also cost USA corporations an estimated $10 billion, as reported by FOX Business.

Instead of multiple pills over days, Xofluza can be administered in just one pill.

Some experts are concerned it could lead to certain flu types developing antiviral resistance.

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.