FDA Approves New Flu Medication, Hoping to Combat Last Year’s Deadly Flu Season in North Texas

As this year’s flu season ramps up, the FDA approved a flu medication with a new mechanism of action for the first time in 20 years. For those who are 12 years or older and have had acute, uncomplicated flu for less than 48 hours, Xofluza (baloxavir marboxil) could be the new answer.

Last year, the flu vaccine was only effective in 40 percent of cases, and the Centers for Disease Control estimates that there were more than 900,000 hospitalizations and 80,000 deaths due to the flu since 2010. Each year, an estimated 3 to 11 percent of the U.S. population gets the flu.

In North Texas, the Dallas Morning News reported that more than 150 people died from the flu last year in DFW, with nearly 7,000 flu and pneumonia deaths statewide.

“The devastation of last year’s flu season underscores the need for new treatment options beyond currently available antivirals or over-the-counter medications,” said Serese Marotta, chief operating officer, Families Fighting Flu via release. “While the flu vaccine is a crucial first step in preparing for flu season and preventing illness, XOFLUZA is an important new treatment option if you do get sick.”

The single-dose pill is made by Genentech, a unit of Roche Group and Shionogi & Co., and blocks an enzyme within the virus, stopping its replication early in the virus’ lifecycle. Clinical trials showed it to reduce flu symptoms by more than a day compared to a placebo. It has shown efficacy against a range of influenza viruses, including drug resistant and avian strains.

The FDA says that the new drug works about as effectively as Tamiflu, which is also made by Roche Group, but Tamiflu is taken twice daily for five days, rather than just once for Xofluza. The worst of the side effects included diarrhea and bronchitis. The AP reports that it will cost $150 without insurance.

“Xofluza is the first new flu medicine with a novel proposed mechanism of action approved in nearly 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 via release. “If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms.”


Keep me up to date on the latest happenings and all that D Magazine has to offer.