US health regulators have approved the first new type of flu drug in 20 years.
Xofluza is a one-dose pill for patients aged 12 and older ahead of the brunt of the winter flu season that can reduce severity and shorten the duration of flu symptoms
However, the US Food and Drug Administration (FDA) said patients must be experiencing symptoms for no more than 48 hours.
Studies showed it cut the amount of time people were sick from 3.3 days to 2.5 days and reduced the length of a fever from 42 hours to one day.
Additionally, it reduced viral shedding – the process by which a virus spreads from one person to another – from four days to one day.
The FDA says that despite the new drug’s approval, it is not a substitute for the vaccine and that getting a shot is the best chance of protection against the virus.
On Wednesday, the US Food and Drug Administration approved Xofluza, a one dose pill for patients aged 12 and older who have had flu symptoms for no more than 48 hours
Each year, the flu typically kills about 12,000 to 56,000 Americans and up to 650,000 people worldwide.
Health officials have said an estimated 80,000 Americans died of the flu and its complications last winter, the disease’s highest death toll in at least four decades.
Across the US, 179 children died and thousands were hospitalized. The Centers for Disease Control and Prevention (CDC) said 80 percent of the children who died were not vaccinated.
The severe flu season increased demand for Tamiflu, a treatment from the same company that developed Xofluza, and led to shortages in individual offices.
‘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 Dr Scott Gottlieb in a statement.
‘This novel drug provides an important, additional treatment option.’
According to a statement from the FDA, Xofluza’s safety and efficacy were tested in two clinical trials involving a total of 1,832 patients.
In both trials, patients received either Xofluza, a placebo, or Tamiflu, which is taken twice daily for five days.
Researchers found that Xofluza alleviated symptoms in a shorter of amount time compared the placebo.
However, people taking Xofluza had symptoms that either ended or were greatly reduced symptoms in just two days on average, similar to Tamiflu.
While Xofluza didn’t work faster than Tamiflu, it did reduce the level of the virus in patients’ nose and throat quicker.
The FDA statement said that 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.
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.
Andrew Villani, senior manager of corporate relations at Genentech, the US-based distributor of the new drug, told CNN that customers who buy the drug without insurance will pay about $150, the same price a Tamiflu.
But he added that patients with commercial insurance that will cover the cost and who use a company coupon could pay as little as $30.
However, the best thing is to not need the drug at all and protect yourself ahead of the brunt of the flu season.
Health officials are encouraging the public to make sure they receive their flu shots, preferably by the end of October.
The CDC recommends getting the vaccine either in the form of a shot or a nasal spray. For those who choose to go with the injectable, there are two options.
The first is a trivalent vaccine, which protects against two influenza A strains, H1N1 and H3N2, and one influenza B strain.
The second option, the quadrivalent flu vaccine, protects against the same strains as the trivalent vaccine, as well as an extra influenza B virus
For the first time in two years, the CDC updated its recommendations to include the nasal spray, known as FluMist.
The nasal spray uses live, weakened viruses which are meant to teach the body to recognize and ward off flu strains if you become infected.
The shot works similarly but uses dead strains of the virus.