Medicine

FDA approves first new flu drug in nearly two decades

FDA approves first new flu drug in nearly two decades

For the first time in almost two decades, the U.S. Food and Drug Administration has approved a new type of antiviral influenza drug.

"With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical", said FDA Commissioner Scott Gottlieb, MD, in a statement announcing Xofluza's approval.

In the clinical trials that were the basis for the drug's fast-tracked FDA review, Xofluza reduced flu symptoms by a little more than a day in healthy patients over age 12.

Further testing is planned to determine whether Xofluza is better than Tamiflu for preventing spread of the flu to others and for treating patients at high risk for hospitalization and pneumonia, such as people with diabetes or lung disease, pregnant women, young children and the elderly.

The Centers for Disease Control and Prevention reports that only 37 percent of Americans got vaccinated for the flu previous year.

"This works by inhibiting, by preventing the replication, the duplication of the virus, so this is very different than the way the Tamiflu works", said Lenchus, "so that's what makes this relatively groundbreaking".

As we head into the middle of flu season, here's what you need to know about the new pill.

Glen Hoddle in hospital after falling ill at BT Sport studio
Hoddle's last managerial position was with Wolves , which he left in 2006 after being with the club for two years. The spokesman declined to reveal the nature of Hoddle's illness but confirmed he did not appear on air.

The FDA approved the drug after multiple clinical trials found it alleviated flu symptoms and helped shorten the duration of these symptoms compared to people who took a placebo. The CAPSTONE-1 and Phase II study results were recently published in the September 6, 2018 issue of the New England Journal of Medicine.

According to CNN, Xofluza is a single-dose pill available by prescription. The treatment will cost $150, although patients with commercial insurance may be able to access the drug for $30. The primary endpoint of the study was time to alleviation of symptoms. It has been shown to significantly reduce the duration of symptoms.

Of course, being a medication, Xofluza still has side effects-the most commonly reported ones were diarrhea and bronchitis, according to the FDA. The study was conducted in the USA and Japan by Shionogi & Co., Ltd. Unlike other now available antiviral treatments, XOFLUZA is the first in a new class of antivirals created to inhibit polymerase acidic endonuclease, an enzyme essential for viral replication.

Flu is a contagious respiratory illness caused by influenza viruses.

A spokesman for Roche, the maker of Xofluza, tells 6 News it believes it can hit pharmacies in the matter of weeks.

The drug, Japanese pharmaceutical company Shionogi's and Roche arm Genentech's Xofluza (or baloxavir marboxil), is different from existing medication in the sense that it attacks the virus through a different method. It's a prescription for that very bad moment when you get the bug but a doctor at Nebraska Medicine says it doesn't take away from the importance of getting a flu shot.


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