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FDA approves first medication to reduce allergic reactions to multiple foods

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Re: FDA approves first medication to reduce allergic reactions to multiple foods

#31

From what I read of this, it's very expensive (thousands/mo), requires at least monthly injections at a facility, has a risk of anaphylaxis (so the injections can't be done at home), doesn't eliminate the risk of allergic reactions, and has no off-ramp (so you have to take it forever). Not exactly a silver bullet... My first thought was that it could be good for kids, who are less good at checking for trace amounts o…

Xolair can be injected at home after the first dose.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#32
post #3

How would this differ from an epipen?

Xolair works by targeting IgE antibodies, which are the part of your immune system that responds to allergens. The shot essentially neuters those antibodies to prevent them from reacting as often/severely, which dampens your body's allergic response across the board. (Crucially, IgE antibodies are not the part of your immune system that responds to infectious disease, so anti-IgE meds won't make you immunocompromised…

Hold on, why even have IgE antibodies then?

Edit: >Several lines of evidence suggest that IgE is important in host defense against parasites (see Section 9-23). Many parasites invade their hosts by secreting proteolytic enzymes that break down connective tissue and allow the parasite access to host tissues, and it has been proposed that these enzymes are particularly active at promoting TH2 responses. This idea receives some support from the many examples of allergens that are enzymes.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#33

Earlier quoted context omitted.

It’s annoying to read “so and so new drug costs too much.” Creating new drugs is absurdly expensive. Most new drugs target small population groups, which is why treatments do not already exist - the low hanging fruit with large market potential gets targeted first. Just be happy a flag is planted in the ground. New drugs will be created from this that are different enough to avoid the patent, and new research will en…

To be fair, Xolair isn't a new drug at all (it's been around for 20-ish years, I think?), this is just a new thing that it's approved for. I'm not sure why a generic hasn't hit the market yet, though. Maybe there's not enough demand to make it lucrative enough, unlike the golden child adalimumab...

IIRC, MABs aren't really a thing, because unlike small molecules, part of the approval is for the whole biological pipeline to produce the antibodies, from cell line to chromatography to formulation. When a small molecule goes off patent, you just have to prove to the FDA you can make that molecule to sufficient purity.

That's not to say there are no generic MABs, it's that it is a far costlier process for the generic manufacturers to get up and running.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#34
I'm a little rusty when it comes to statistical analysis, but is 168 total participants ranging from 1 to 56 years old really enough for any meaningful level of statistical significance?

Sure the efficacy rates seem really promising here, but that's an extremely small group and if there are any concerns over age-based factors the cohorts are even smaller.

Add the fact that this medication is meant for long term use and I really don't know how we can claim any level of certainty with regards to long term safety. The study only followed the 168 participants (including placebos) for 16-20 weeks.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#35
It's a 16 to 20 week course of treatment and reduces risk of anaphylaxis for accidental exposure to food allergens. There is at least one other drug that is used to treat peanut allergies, but this treats multiple food allergies.

Given that anaphylaxis can be deadly and staff at food places can be sometimes less than reliable about food allergy concerns, I can see this being appealing to someone with severe food allergies who wants a more normal life.

It would be nice if we figured out what causes allergies and fixed it but, I mean, we may never fully solve that. For some people, "take injections for a few weeks and be able to go out with friends without stressing this will involve another life-threatening health event and trip to the ER" will be of adequate value to endure the course of treatment.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#36

From what I read of this, it's very expensive (thousands/mo), requires at least monthly injections at a facility, has a risk of anaphylaxis (so the injections can't be done at home), doesn't eliminate the risk of allergic reactions, and has no off-ramp (so you have to take it forever). Not exactly a silver bullet... My first thought was that it could be good for kids, who are less good at checking for trace amounts o…

Longtime Xolair patient here: as far as cost goes, there are copay programs that knock the price down to $5/mo, but the catch is that you have to be insured (via commercial health insurance, not Medicare/Medicaid) to qualify. A lot of drug manufacturers offer these programs: the bargain is essentially that they'll cover the brunt of your copay cost so long as your insurance company is still paying for the rest of it.…

So hard to believe that this is so complicated. People’s lives and health. I wish it was easier.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#37

Earlier quoted context omitted.

Xolair works by targeting IgE antibodies, which are the part of your immune system that responds to allergens. The shot essentially neuters those antibodies to prevent them from reacting as often/severely, which dampens your body's allergic response across the board. (Crucially, IgE antibodies are not the part of your immune system that responds to infectious disease, so anti-IgE meds won't make you immunocompromised…

Hold on, why even have IgE antibodies then? Edit: > Several lines of evidence suggest that IgE is important in host defense against parasites (see Section 9-23). Many parasites invade their hosts by secreting proteolytic enzymes that break down connective tissue and allow the parasite access to host tissues, and it has been proposed that these enzymes are particularly active at promoting TH2 responses. This idea rece…

Yep, you got the gist in the ninja edit.

The IgE-parasite connection is actually a bit part of the hygiene hypothesis, and I have personal experience with helminth therapy. It put a serious permanent dent in my animal and pollen allergies, long after the session (I forget how long they were active but I re-inocculated N. americanus twice and it was roughly a 2-3 year period).

Once you get over the squick factor and the really terrible itching at the site that lasts 12-24h, it's great.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#38

Very expensive Not a great side effect profile Not even very effective Yup sounds like medicine in the 21st century. I think we're going to cull ourselves as a species because we're not at all aligned with doing things that actually make people healthier, unless that also happens to make good money.

Would you prefer the alternative of the 20th century, where this drug doesn’t exist at all?

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#39

I'm a little rusty when it comes to statistical analysis, but is 168 total participants ranging from 1 to 56 years old really enough for any meaningful level of statistical significance? Sure the efficacy rates seem really promising here, but that's an extremely small group and if there are any concerns over age-based factors the cohorts are even smaller. Add the fact that this medication is meant for long term use a…

It went from like 6% to 68%, so yeah it’s statistically significant even at low numbers like 168.

Re: FDA approves first medication to reduce allergic reactions to multiple foods

#40

[flagged]

A) hygiene hypothesis, people ate way more dirt and straight up almost everyone had worms

B) the people with really bad food allergies like Coeliac just died young.

We have severe amnesia when it comes to just how rough the state of health was until basically the 50s (eradicating Polio is a big turning point). Fortunately, we can learn about history so we don't repeat it :massive eyeroll:

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