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Next winter, there may be a new drug for people who contract the flu – a drug that appears to be able to quickly stop the infection and, unlike anything found on the market, can be taken in a single dose
The Food and Drug Administration said Tuesday that the drug, baloxavir marboxil, would be the subject of a priority review, and that its approval could change the flu treatment.
Baloxavir marboxil has already been registered in Japan, where it is sold by Shionogi & Co. under the trademark Xofluza. Roche has bought most of the world's drug rights – Shionogi retains rights in Japan and Taiwan – and Genentech, a Roche company, is developing the drug for the US market.
The FDA told Genentech that it would make a decision on baloxavir marboxil within six months – in other words, before Christmas.
It has been shown that the drug reduces the duration of influenza symptoms from a little more than a day – most uncomplicated influenza infections last only a few days. fever duration of nearly a day. It also significantly reduced the time that people with the flu coughed and sneezed viruses – a potential benefit for people around these sick people.
Here's what you need to know about this medicine. 19659008] A fast-acting, powerful single-dose drug is important
Whenever you can make a drug easier to take, the chances of people taking it and taking it properly increase. Public health authorities believe that flu drugs are underused, so a drug that works well and attracts more doctors and patients would be a step forward.
Other flu medications may be known as Tamiflu. For five days
Second, this drug works differently than all others – and there are not many others – on the market. It is an inhibitor of endonuclease; This is the first new class of influenza drugs marketed for more than two decades.
There are only two other classes of influenza drugs, neuraminidase inhibitors (Tamiflu, Relenza, Rapivab) and adamantanes (amantadine and rimantadine). ). This last class is not recommended because influenza viruses quickly develop resistance to these drugs.
New classes of drugs are always welcome as they provide protection if influenza viruses develop resistance to existing drugs. According to Richard Webby, director of the influenza collaboration center of the World Health Organization at the St. Jude Children's Research Hospital in Memphis, "relying solely on a class of drugs can have a impact on public health. "I think the more compounds we have, the better."
Another class of flu drugs opens up the possibility of using drugs in combination to reduce the risk that viruses develop drug resistance, Webby said. studied another experimental drug in this class, but is not involved in marketing baloxavir marboxil
How it works
The drug interferes with a key step in the process of infection of the influenza. Influenza viruses invade human airway cells and use these cells as mini-factories to pump swarms of copies of themselves that come off to infect other people.
Endonuclease Inhibitors Stop This Copying Process
Mark Eisner, Genentech's Vice President of Product Development for Immunology, Infectious Diseases and Ophthalmology, said that The clinical trial used to prove that the drug worked registered subjects aged 12 years and older. It is therefore likely that if the FDA approves the drug, it will be approved for the same patient population.
Additional studies will be conducted to test the safety and effectiveness of the drug in young children. Others will test to see if the drug benefits people hospitalized with severe influenza infections.
When it hits the market
If the FDA approves baloxavir marboxil, will it be available next season?
"We are working very hard to make it available as soon as possible after approval and we will work with the FDA to do everything we can to speed up [availability]," said Eisner.
The Great Unknown
The price set for this drug will be crucial. How many people are willing to spend to reduce a flu episode for a day or two?
Genentech said that it was too early to comment on the cost of the drug. In Japan, the drug is selling at the equivalent of about $ 43.50
A related unknown
Tamiflu and other drugs in its category have never been accepted by the market in the United States that their manufacturers were hoping and the public health authorities were hoping to get
The reason: One has the impression that the benefits – a little less time spent in bed – do not warrant to try to get a doctor's appointment, to go to the doctor and find a pharmacy with the drug in stock. Many doctors are also disappointed with drugs, and are not inclined to prescribe them.
Then there is the question of the treatment window. Neuraminidase inhibitors work best if treatment begins within 48 hours of the onset of symptoms. After that, in cases of uncomplicated influenza, you are in the field of diminishing returns since the symptoms of most patients begin to dissipate on their own.
Baloxavir marboxil should also be taken in this 48 hour window. The question of the new drug will be this: Is the prospect of a fast-acting, single-dose treatment supplanting skepticism with respect to flu medications? Webby said that it is possible that the "unique" nature of the drug may increase the use.
Reissued with permission of STAT. This article was published on 27 June 2018
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