Edwin H. Kim, MD, is an associate professor of pediatrics at University of North Carolina’s School of Medicine.

Edwin H. Kim, MD

Sayantani Sindher, MD

Michelle Huffaker, MD

 is a phenomenon that touches the lives of almost everyone in some way, whether one is a patient or has a relationship with a patient.

Allergies to food are a significant concern, given the potential for anaphylaxis among those with Type 1 hypersensitivities. In fact, close to 200,000 individuals require emergency medical care for allergic reactions to food allergens and more than 50% of the 33 million adults in the US with food allergies report experiencing severe reactions.

Parents had become concerned over the years about their children reacting to food allergies, so protocols for avoidance of allergens became the norm by the outset of the 21st century. The 2000 recommendations by the American Academy of Pediatrics (AAP) urged avoidance of major allergens such as peanuts, milk, and eggs.

Allergies to these food products appeared to rise among children in the US between 2000 - 2009.

 It was only recently that the allergy research space made a dramatic shift away from avoidance and toward early exposure and immunotherapy, resulting in the landmark 

US Food and Drug Administration (FDA) approval

 in 2020 of AR101 (Palforzia) as the first food allergy-related immunotherapy.

Since 2020, this dramatic shift in the field of food allergy research has given way to a variety of advancements. 2024 represented another major leap forward, with 2 significant FDA approvals: 

Omalizumab was the first treatment designed to prevent anaphylaxis resulting from exposure to 1 or more food allergens in adults and childrens aged 1 year and older with immunoglobulin E (IgE)-mediated food allergies. Epinephrine nasal spray, also known as ‘neffy,’ is the first alternative option to injectable epinephrine (in such products as the EpiPen).

 editorial team reached out to 3 experts in the field of allergy research to discuss these notable advancements, their significance as ‘firsts’ in the allergy space, and what they mean for patients now that they have been approved.

The team spoke with Edwin H. Kim, MD, associate professor of pediatrics at the University of North Carolina’s School of Medicine. We also spoke with Sayantani Sindher, MD, a clinical associate professor of allergy and immunology at Stanford Medicine. Our third expert was Michelle Huffaker, MD, the director of clinical translational medicine in the Allergy Portfolio at the Immune Tolerance Network.

Each of these speakers are leading experts in the field of allergy and immunology. Below are several notable quotes from 3 interviews on the topic of the aforementioned developments in the allergy space in 2024.

On Evolving Allergy Research and New Developments:

 I would absolutely agree that this has been the biggest year I could think of when it comes to food allergy therapeutics and treatment options. Really thinking back over many years, it's really just been about diagnosing the allergy and giving guidance and avoidance. Several years ago, we had the approval of peanut oral immunotherapy as well as clinical use of food products for this type of thing.

But these were very sort of narrow types of treatments that were only available through specialized clinics. So omalizumab being approved by the FDA is a dramatic change when it comes to food allergy. One of the biggest reasons, in my mind, is because pretty much every allergy office in the United States at this point is likely offering omalizumab for asthma or for hives and urticaria. So now to be able to offer that same medication that they have so much experience with for food allergy, inevitably, is going to increase access.

 It felt like a very momentous year for food allergy, with omalizumab, with neffy, and in fact with another product, Palforzia. The age range went down even lower, as it was previously 4 and up and now it's been shifted to 1 year olds and up. That's extending the age group for when we can offer therapies.

I think having all these treatment options early on changes the mindset when we think of allergy care, instead of what we used to do forever where we diagnose and we say ‘Okay great, now you just avoid it, hope for the best, and we'll see what comes around down the line.’ Whereas now, when I'm diagnosing a 5-month-old or 6-month-old, I can provide them with ‘You know, when you turn 1, you have these options.’ There are these other treatment options in the pipeline and there's just a lot more opportunities for patients to decide what's the right track for them.

The patients are very grateful to have options now. For years, it was avoidance and epinephrine auto injectors. And now they are very grateful that the field is moving forward and that there are more treatment options available, even if they don't just choose to elect those treatment options at this time. There are a variety of reasons that they might choose not to, but just having choices and options has really changed things for those patients.

On Omalizumab and Its Impact on Patients:

I think the earliest patients are on the therapy at this point. So it will take a little bit of time to really get an assessment of how this truly affects those patients. We know what to expect from the clinical trials, but real life is not always the same. I do want to bring up the point that I started with previously, that it increases access and one of the biggest things that it does is (function as) a treatment that can be given for any and all food allergies.

So it really can potentially address food allergies for almost every patient that's out there. The prior treatments, the oral immunotherapy, really could not. It will be really interesting to see the effect that this treatment has on patients, as well as whether there are ‘ideal patients’ for this or patients with certain food allergies do better than those with other food allergies. (There are) lots of these types of questions, so we can fine tune how we use this in the clinic.

I still remember when it got approved. I was away internationally, and I started getting texts from all my colleagues, along with emails. Patients were reaching out when the FDA first approved it, so my colleagues and I have been very excited about this development…One of the reasons I'm super excited is that it gives patients and families choices, because that's one of the things I am hoping for, with more and more advancements coming through…It is great for anyone who doesn't want the hassle of daily oral immunotherapy, which we can address later.

This has been a very exciting year for the world of food allergy and for patients and families dealing with food allergies. And one word you said there really hits on how omalizumab changes the landscape, and that's that's the word ‘options.’ Traditionally, food allergies have been managed completely with avoidance and managing reactions with epinephrine.

It can be frightening for patients. It can be frightening for families. It can be very challenging to avoid all the food allergens and what omalizumab does is it's an extra safety net against those accidental exposures. So decreases the likelihood that anaphylaxis will occur if you were to have an accidental exposure. And so it really opens up options for patients, it potentially liberalizes their diet. It also really changes the level of anxiety that there may be around food allergy.

On the Impact of Epinephrine Nasal Spray:

 I think this has the potential to have a dramatic effect, because every patient out there who has food allergy should have an epinephrine auto-injector to be used as treatment if they were to have an allergic reaction. So a change to that has the potential to affect pretty much every patient that's out there. We know that this is separate from the treatments, because the treatments are there to prevent allergic reactions, but when allergic reactions happen, we know that epinephrine is the best medicine.

That first line medicine that will treat all the symptoms and ideally prevent symptoms from becoming more significant or more severe. At the same time, what we have understood anecdotally, but also now more from actual data on usage, is that a lot of folks that could and should be using that epinephrine auto-injector just haven't been for a multitude of reasons. One of the biggest ones being the injection route itself. So now to have a medication that I hope people are going to be more willing to use, it'll be fantastic to see what kind of effect this will have from the usage of the medication and, hopefully, prevent more significant allergic reactions.

 I think a lot of our adolescent patients are very excited. They love the idea of just being able to spray in their nose and not the injection. We've had so many. We do a lot in our research unit and we do a lot of food challenges. As part of participation in a clinical trial, we have to show that you are truly allergic to a food, and the gold standard of diagnosis is giving them the food that they're allergic to and waiting for a reaction and then treating that reaction.

So we see kids and adults just more terrified about the injection than about the reaction itself. We've had patients who have sat through anaphylaxis on their own because they didn't want to inject themselves. There's also user error. Some parents may have injected themselves instead of the child in the process. So there's lots of kinds of barriers to getting optimal care when it comes to the injectables.

It is another exciting new option for patients in the world of food allergy. It's still kind of coming into the market, so we're still seeing how patients are adopting it. I think one thing that I'm hopeful about with it is that it will lower the bar for use of epinephrine. Giving yourself an injection often feels like a very big deal to patients, even though that really should be the first thing they turn to with systemic allergic reactions. Previously, we only had that through injection.

What I'm hoping is that patients that may be hesitant to give themselves an epinephrine injection would potentially give themselves a nasal spray of epinephrine, if the treatment is just as effective as the injectable form. As a clinician, I don't care which one gets into them, but I want one of them to get into them for patients having a reaction. So if the nasal spray can lower that bar for use, its has potential to save lives.

The quotes contained in this article were edited for the purposes of clarity. For further information, view the interviews posted above.

Kim has reported consulting fees from ALK-Abelló, Ukko Inc., Cellergy Pharma, DBV Technologies, Genentech, Hanimune Therapeutics, Novartis, Nutricia, Phyalxis BioScience, and Revolo Biotherapeutics; safety review committee membership with Allergy Therapeutics Ltd.; royalties from UpToDate; and has stock options for Cellergy Pharma.

Sindher has reported receiving research grant support from NIH, FARE, CoFAR, DBV, AIMMUNE, and Regeneron and has worked as an advisor for Genentech.

Facts and Statistics. Food Allergy Research & Education. https://www.foodallergy.org/resources/facts-and-statistics?gad_source=1&gclid=Cj0KCQiAm4WsBhCiARIsAEJIEzXD8KiNDPvqo8HvRtRBBTjbmyyWhktLJrOiNjLUEqTNRSyo_6_4Z3caAl0JEALw_wcB. Date accessed: December 16, 2024.

Committee on N. Hypoallergenic infant formulas. Pediatrics. (2000) 106(2):346–9. 10.1542/peds.106.2.346. Date accessed: December 16, 2024.

Branum AM, Lukacs SL. Food allergy among children in the United States. Pediatrics. (2009) 124(6):1549–55. 10.1542/peds.2009-1210. Date accessed: December 16, 2024.

FDA approves Xolair® (omalizumab) as first and only medicine for children and adults with one or more food allergies. Novartis. February 16, 2024. https://www.novartis.com/us-en/news/media-releases/fda-approves-xolair-omalizumab-first-and-only-medicine-children-and-adults-one-or-more-food-allergies#:~:text=EAST%20HANOVER%2C%20N.J.%2C%20Feb.,patients%20aged%201%20year%20and. Date accessed: December 16, 2024.

Office of the Commissioner. FDA approves first nasal spray for treatment of anaphylaxis. U.S. Food and Drug Administration. August 9, 2024. Accessed August 9, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-nasal-spray-treatment-anaphylaxis. Date accessed: December 16, 2024.

Videos

Kim, Sindher, Huffaker spoke with HCPLive about some of the year’s most important developments in the food allergy space, namely the approvals of omalizumab and neffy.

Edwin H. Kim, MD

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