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FDA Approves First New Flu Drug In 20 Years (popsci.com)

An anonymous reader quotes a report from Popular Science: The Food & Drug Administration just announced that they had approved the aptly-named Xofluza, the first new antiviral drug in two decades, to help alleviate the symptoms of a flu infection. The reason Xofluza got a priority review from the FDA is that it works through a different mechanism than Tamiflu. Both are antivirals, meaning they prevent the replication of the virus, but they work at different stages in that process. First, a quick primer on how viruses infect you: a virus is basically a packet of genetic material that injects itself into a cell and hijacks the cell's normal replication machinery, forcing it to produce millions of copies of the virus. A protein called viral neuraminidase allows those copies to exit the cell and go infect new parts of your body. Most of our effective antivirals are neuraminidase inhibitors -- the virus can still replicate, but it's prevented from escaping.

Xofluza works by preventing the viral replication in the first place. It blocks viral polymerase, an enzyme that helps make copies of the invading genetic material. This doesn't necessarily make it better or more effective -- the FDA notes that early trials suggest it's about as effective as Tamiflu -- but as the FDA Commissioner Scott Gottlieb pointed out in a press release, "Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs."

39 comments

  1. Great by Anonymous Coward · · Score: 0, Flamebait

    Another way to catch autism.

    1. Re:Great by Presence+Eternal · · Score: 1

      I agree. The only natural cure is more cowbell.

    2. Re:Great by Anonymous Coward · · Score: 0

      And fluorine poisoning. Unlike Tamiflu, Xofluza is fluoridated.

  2. 20 Already? by Scarletdown · · Score: 4, Funny

    It's been 20 years already? Goodness, how time flu...

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    This space unintentionally left blank.
    1. Re:20 Already? by schizz69 · · Score: 1

      Side effects include: hair loss, narcissism and an orange glow to your complexion.

    2. Re:20 Already? by Anonymous Coward · · Score: 0

      best president in my lifetime and im old enough to be alive during bill clinton

    3. Re: 20 Already? by Anonymous Coward · · Score: 0

      Poor kid. Most of us remember Bush senior.

    4. Re: 20 Already? by reboot246 · · Score: 1

      Poor kids. I remember Eisenhower.

    5. Re: 20 Already? by Anonymous Coward · · Score: 0

      Fortunate kids, I reminder Joseph Stalin. Why get the flu when someone can just starve you to death.

  3. Another advantage by vbdasc · · Score: 2

    There is another advantage of having drugs that work on different phases of the pathological process. It is that they can often show synergism when taken together, and such a combination has the potential to become the most effective treatment.

    1. Re:Another advantage by gtall · · Score: 0

      "synergism"...back to MBA-Land for you, Grasshopper.

    2. Re:Another advantage by Anonymous Coward · · Score: 1

      They really ignited the innovation pipeline on this one*. Probably because of they were so laser focused**.

      * please don't ignite pipelines, it's usually a bad ting
      ** lasers aren't focused, they're collimated

  4. Alternative autism. Great. by Petersko · · Score: 1

    Low hanging fruit, I know...

  5. Doesn't matter by Anonymous Coward · · Score: 0

    1) no one will be able to afford it
    2) in this age of social media vs facts, the anti-vaxers (or some other loud mouth ignorant group) will convince the majority its evil.

    1. Re:Doesn't matter by Anonymous Coward · · Score: 0

      welcome to socialism, comrade, where The People's word is law.

    2. Re:Doesn't matter by LostMyAccount · · Score: 2

      With Tamiflu, I think for it to be worth taking you have to take it within some short time window of developing symptoms (48 hours?). Since it's prescription, this means getting into a reasonable doctor's office right away. I think this prevents most people from getting any benefit out of it, but the time you're really sick it's too late, and even if you were somehow on top of it, now you have to get into the doctor, etc, in that time frame. Another drug with similar limitations doesn't seem like it would be of much use. They need some kind of anti-flu drug that's safe enough to get OTC and that doesn't contribute to drug resistance for all the people who would take it without actually having the flu.

    3. Re:Doesn't matter by Anonymous Coward · · Score: 0

      With Tamiflu, I think for it to be worth taking you have to take it within some short time window of developing symptoms (48 hours?). Since it's prescription, this means getting into a reasonable doctor's office right away. I think this prevents most people from getting any benefit out of it, but the time you're really sick it's too late, and even if you were somehow on top of it, now you have to get into the doctor, etc, in that time frame. Another drug with similar limitations doesn't seem like it would be of much use. They need some kind of anti-flu drug that's safe enough to get OTC and that doesn't contribute to drug resistance for all the people who would take it without actually having the flu.

      And you have a sick person spreading the virus to the vulnerable people at the doctor's office.

  6. Re:Linus was blackmailed by Anonymous Coward · · Score: 0

    There have been several high profile security bugs on Linux in the past weeks.

  7. the real truth by slashmydots · · Score: 0

    Want to know a secret? It's diet 7-up, the famous long-time white people cure.

    1. Re:the real truth by Anonymous Coward · · Score: 0

      Shasta makes niggas gay

  8. But by Anonymous Coward · · Score: 0

    Why not both? Wouldnt taking both really inhibit the spread of a virus? It cant copy, and if it did it couldnâ(TM)t escape, and even if it did those shouldnt be able to replicate and the immune system will have some fun with them

    1. Re:But by omnichad · · Score: 1

      Well sure, but the scientific method precludes going straight for the double treatment, as does the FDA. If it's made by a different drug makes than Tamiflu, then they have no interest in promoting that either. And even if the patent expired on Tamiflu, they probably want to patent the (obvious) combination drug several years down the road rather than give a more effective treatment now. Longer patent dominance.

  9. Because of resistant strains. Might do it though by raymorris · · Score: 2

    As the summary says, that might be the best treatment. One reason NOT to do that is that the flu virus changes every year, becoming reistant to the anti-bodies that worked against last year's flu. If you routinely give both drugs, it's likely the fluvirus will adapt to be resistant to both. In some ways, it's better to keep one in reserve as a "secret weapon" that the virus doesn't know about, and only pull it out when needed. "When needed" might be vulnerable people (old, babies, aids patients) and/or when Tamiflu isn't working.

  10. What the Synopsis Might Also Have Mentioned by rea1l1 · · Score: 0

    A Quick Public Health Alert:

    Today, more people are dying from antibiotic resistant bacteria than they are from HIV/AIDS. Our abuse of antibiotics has caught up with us. This could very well turn into a lethal pandemic. A major reason our society abuses antibiotics is the meat industry: the constant administration of antibiotics to livestock results in animals twice the mass. Thus, the meat industry utilizes actual TONS of antibiotics yearly to double their product.

    The synopsis mentioned: the FDA Commissioner Scott Gottlieb pointed out in a press release, "Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs."

    What should also have been included in the synopsis is why it's important to have more than one antiviral. There is of course the obvious "more tools the better", but the real reason is that when targeting microbes it's important to ALWAYS attack with at least two weapons at the same time so as to ensure we aren't merely breeding resistant mutants. If only one antimicrobial is utilized, there is a very good chance that every other bacteria is wiped out except the few cells that have a mutated resistant gene, leaving that cell little competition to contend with growth-wise, and thus resulting in a culmination of resistant microbes. If two antimicrobials are utilized, it is MUCH less likely that there are two microbes that have developed resistance to both weapons simultaneously, and thus we are ensuring none survive.

    This is why doctors should ALWAYS prescribe at least two antimicrobial agents at a time.

    If you do not follow your doctors recommendations for antimicrobial use, you are likely breeding a new form of drug-resistant microbe inside of you.

    In addition, many bacteria have the ability to directly share genes among each other, even between entirely different species of bacteria, via a process called conjugation, in which they directly transfer a gene or set of genes via a microtubule between eachother.

    1. Re:What the Synopsis Might Also Have Mentioned by Anonymous Coward · · Score: 0

      Go back to 1st grade and re-learn the difference between Virus and Bacteria.

      Learn which-is-which, which comes first and which second, learn how different drugs work differently on those.

      And then fix your broken comment.

  11. Prevention by ChrisMaple · · Score: 0

    Get adequate vitamin D (which the RDA is not) and you'll greatly reduce the risk of getting any variety of flu.

    --
    Contribute to civilization: ari.aynrand.org/donate
    1. Re: Prevention by Anonymous Coward · · Score: 1

      Bull shit. It's a virus. Assuming no immunity, once it gets inside it hijacks the cellular programming to make more viri. It's a program. Vitamins won't do fuck-all to stop it. At best, it just help the recovery repair damage after the fact.

    2. Re: Prevention by Anonymous Coward · · Score: 0

      Not to mention anything that strengthens the immune system will strengthen the immune response, which makes symptoms STRONGER not weaker as your body fights off the virus. People who claim they never get symptoms of sickness often have weak immune systems, not strong ones.

    3. Re:Prevention by Obfiscator · · Score: 1

      I am genuinely interested if you have an article to share on this. I spent a lot of time last year looking at peer-reviewed scientific literature studying the effect of nutrition on illness prevention and cure, and I don't remember seeing anything about vitamin D and the flu (either for or against). So I didn't even realize this was a thing.

      --
      "Nothing shocks me. I'm a scientist." -Indiana Jones
  12. Cool name. by Anonymous Coward · · Score: 0

    When you say it out loud, it sounds like you're sneezing. Should boost sales.

    1. Re: Cool name. by cyberchondriac · · Score: 1

      Next to get FDA approval: GeXuntite.

      --

      Look back up at my post, now look back down, you're on the Internet. Now look back up. I'm a signature.
  13. More Big Pharma fraud by Anonymous Coward · · Score: 0

    This snake oil won't prevent any flu, neither does 'Tamiflu'.

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