Sunday, 20 January, 2019

Genentech Announces FDA Approval of XOFLUZA (Baloxavir Marboxil) for Influenza | Small Molecules

Nurse Nicole Simpson prepares a flu shot at the Salvation Army in Atlanta on Feb. 7 2018 Nurse Nicole Simpson prepares a flu shot at the Salvation Army in Atlanta on Feb. 7 2018. David Goldman AP
Melissa Porter | 28 October, 2018, 04:12

The Xofluza approval isn't just a milestone for flu drug development, though-it's a potential landmark for FDA drug approvals at large.

USA health regulators have approved the first new type of flu drug in 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. And honestly, the more flu medication options the better: "Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs". "This novel drug provides an important, additional treatment option", Scott Gottlieb, MD, FDA commissioner said.

There's a new drug on the market to help fight the flu that doctors believe could be a game-changer.

Regulators cautioned, however, that antiviral drugs to treat already developed flu symptoms aren't a substitute for vaccination.

XOFLUZA will be available across the the coming weeks. CNN further notes that when patients with the flu are treated with antiviral drugs within 48 hours of getting sick, both the symptoms and duration of the respiratory illness can be significantly reduced. In the second trial, the time to symptom relief was the same for patients who received Xofluza and those who received the other antiviral treatment, according to the FDA.

Xofluza is unusual in that it is taken in a single dose. One major advantage of Xofluza is that it's administered in a single dose as opposed to the five days of therapy that Tamiflu requires. Current treatments - including existing vaccines and antiviral drugs - have limitations as flu viruses are constantly changing and new antiviral medicines are necessary. That's just six shy of the all-time record of 53 new drug approvals in 1996, and it's not even November yet.

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.

"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".

The FDA says Xofluza's safety and efficacy was demonstrated in two randomized controlled clinical trials of 1,832 patients.

The top side effects found in the studies were diarrhea and bronchitis, according to the FDA. But here's the catch: It only works if the person has had flu symptoms (like fever, muscle aches, and fatigue) for less than 48 hours. Practicing good overall self-care, like sleeping enough, managing stress, eating well, and getting regular exercise, can also help. You will need a prescription to get it.