Health Care

Flu Season: FDA Approves New Influenza Treatment

Flu Season: FDA Approves New Influenza Treatment”

"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 Sandra Horning, M.D., chief medical officer and head of Global Product Development.

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. "This novel drug provides an important, additional treatment option", said FDA Commissioner Scott Gottlieb, M.D., in a statement. The approval is for people who are 12 or older.

For the first time in almost two decades, the U.S. Food and Drug Administration has approved a new type of antiviral influenza drug. The most common side effects in patients taking Xofluza were diarrhea and bronchitis.

Every year, the seasonal flu virus infects 5 to 20 percent of Americans and can lead to tens of thousands of deaths.

"The devastation of last year's flu season underscores the need for new treatment options beyond now available antivirals or over-the-counter medications", said Serese Marotta, chief operating officer, Families Fighting Flu.

Regulators cautioned, however, that antiviral drugs to treat already developed flu symptoms aren't a substitute for vaccination. Tamiflu is taken twice daily for five days.

Participants were assigned to receive either the drug, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms.

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. There have already been a handful of deaths as a result of the flu so far in the USA, and previous year the flu killed 80,000 individuals.The drug, known generically as baloxavir marboxil but sold under the brand name Xofluza, was invented and is manufactured by the Japanese company Shionogi & Co.

Similar to Tamiflu, it needs to be taken within 48 hours of developing symptoms to be effective. In February 2018, it was approved in Japan for the treatment of influenza types A and B. While the efficacy of Roche's Xofluza (baloxavir marboxil) is similar to that of Roche's Tamiflu, it will play a role in the armory of drugs against what can be a deadly infection. "Having more variety is good for a variety of reasons, including that the less medications you have to take, the better the compliance".



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