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FIRST DRUG FOR ACCIDENTAL FOOD ALLERGIES GETS FDA APPROVAL

Mya Care Blogger 06 Mar 2024
FIRST DRUG FOR ACCIDENTAL FOOD ALLERGIES GETS FDA APPROVAL

Food allergies are a common health concern that affects millions of people worldwide. Accidental exposure to allergens can cause severe and potentially life-threatening reactions. For years, the only way to manage food allergies was to avoid the allergen altogether. However, the Food and Drug Administration (FDA) has recently approved the first medication to reduce accidental food allergy reactions.

This article will discuss the FDA approval for this medication, its role in managing food allergies, and its potential benefits and drawbacks.

Understanding Food Allergy

A food allergy ensues when a food protein triggers an immune system response. Upon ingesting an allergen, the body produces an antibody called immunoglobulin E (IgE). IgE plays a crucial role in the allergic response by binding to allergens and triggering the release of histamine and other chemicals.

The process of IgE production is intricate and begins with introducing an environmental allergen into the body. Antigen-presenting cells (APCs) capture the allergen, process it, and present it to T and B lymphocytes. This leads to the activation of B-lymphocytes and the production of allergen-specific IgE from blood plasma cells.[1]

IgE binds to the cell receptors of basophils and mast cells, activating them and promoting the release of histamine and other chemicals. This event leads to allergic reactions, including itching, swelling, allergic asthma, hives (urticaria), and other symptoms.

In scenarios of food allergy, the immune system responds to a specific food protein. The most common food allergens include:

  • Soy
  • Wheat
  • Peanuts
  • Tree nuts
  • Milk
  • Eggs
  • Fish
  • Shellfish

These allergens can cause various symptoms, from mild hives and itching to severe anaphylaxis, which can be life-threatening.

Currently, the only sure way to manage food allergies is to avoid the allergen altogether. This can be challenging, especially for those with multiple food allergies. Accidental exposure to an allergen can happen at any time, and avoiding allergens in social situations or when dining out can be difficult.

Alternate methods pose similar risks, especially building oral tolerance to an allergen through gradual exposure. Individuals with intense allergies must always be vigilant, keep an EpiPen accessible, and have medical documentation of their allergy on hand in the event of experiencing an anaphylactic reaction.

The recent approval of Xolair for allergic reactions may offer some relief to those with severe allergies, helping them to manage their symptoms better and avoid a life-threatening situation.

Xolair's Role in Managing Food Allergies

Xolair (Omalizumab) is a medication that has been used since 2003 to treat moderate to severe asthma.[2]

In February 2024, the FDA approved Xolair for use in reducing allergic reactions in adults and children over one year of age with multiple food allergies.[3]

Xolair's approval is a significant step forward in managing food allergies. It provides a new option for those with multiple food allergies and may help reduce the fear and anxiety that comes with accidental exposure. However, it is essential to note that Xolair is not a cure for food allergies and does not eliminate the need for avoiding allergens.

It also has official approval to treat[4]:

  • Allergic asthma in those aged six years and older in whom an asthma pump (inhaled corticosteroids) does not help
  • Chronic hives without a known cause in those older than 12 years when antihistamines are ineffective
  • Chronic rhinosinusitis with nasal polyps in those over the age of 18 if nasal corticosteroids fail to control symptoms

A Xolair vial contains Omalizumab, sucrose, L-histidine hydrochloride monohydrate, L-histidine, polysorbate 20, and other ingredients. The main ingredient, Omalizumab, is a monoclonal antibody that binds to human immunoglobulin E (IgE). It is produced using Chinese hamster ovary cell cultures.[5]

While Xolair is not the first anti-allergy drug, it is the first non-specific anti-allergenic drug that blocks IgE antibodies.

How Does Xolair Work?

Xolair targets and blocks the IgE antibodies responsible for triggering allergic reactions. It only blocks free IgE, leaving bound IgE and IgE receptors unaffected. By reducing the number of IgE antibodies, Xolair can decrease the severity of allergic reactions and potentially prevent anaphylaxis.

It is administered as an injection under the skin every 2 or 4 weeks. The quantity of administered Omalizumab and the frequency of injections depends on the individual's weight and IgE levels. Patients over 12 years can self-inject with Xolair after ascertaining an optimal dose with a healthcare provider.

Is Xolair a Replacement for Avoiding Allergens?

No, Xolair is not a replacement for avoiding allergens. Avoiding the allergen as much as possible is essential, even when taking Xolair. Xolair is an additional tool to reduce the risk of accidental exposure, reactions, and anaphylaxis.

What are the Benefits and Drawbacks of Xolair?

The main benefit of Xolair is its potential to lower the risk of accidental allergic reactions.

In the OUtMATCH trial[6], a large study conducted on 177 children, the active ingredient Omalizumab proved effective at increasing their tolerance for multiple food allergens, including peanut, cashew, milk, and egg.

The primary endpoint was defined as the ability to ingest 600mg of peanut protein without any side effects. 67% of the participants who received Omalizumab met the primary endpoint, compared to only 7% of those who received the placebo.

The secondary endpoint assessed the children's ability to ingest 1000mg of cashew, milk, and egg without side effects. The results are as follows:

  • 41% of Omalizumab recipients could eat cashews without side effects vs. 3% with a placebo
  • 66% of Omalizumab recipients could drink milk without side effects vs. 10% with a placebo
  • 68% of Omalizumab recipients could eat eggs without side effects vs. 0% with a placebo

For many allergic individuals, this treatment can provide peace of mind for those with food allergies and their loved ones. Xolair may also help reduce the severity of allergic reactions, making them more manageable.

In another study, Omalizumab enhanced the outcome of using oral immunotherapy in allergic individuals exposed to multiple allergens.

Drawbacks

As Xolair only binds to free IgE and cannot bind to all IgE, there is still a chance that those using the therapy are susceptible to allergic reactions, especially if they consume the allergen in high doses. Therefore, it might be more suited to prevent severe reactions due to accidental intake of small amounts.

Potential drawbacks of Xolair include:

  • Xolair can be expensive, with varying insurance coverage
  • It is not a cure for food allergies or a substitute for avoiding allergens
  • It requires regular injections, which may be inconvenient
  • Xolair comes with risks, side effects, and long-term complications for susceptible individuals, one of which includes allergy
  • The treatment is not suitable for all individuals

Potential Side Effects of Xolair

The side effects reported in clinical trials include injection site reactions, muscle pain, fever, and rash. They typically occur 1-5 days after treatment.[7]

Those vulnerable to parasite infections may acquire one after Xolair treatment.

A few reports show that Xolair can cause cardiovascular inflammation and symptoms such as shortness of breath, chest pain, a rash, pins and needles, or numbness in the hands and arms. These symptoms are linked to those with asthma using oral steroids who cut down on their dose before using Xolair.

In rare cases, Xolair may also cause anaphylaxis, so it is essential to have a plan in place for managing allergic reactions while taking this medication.

If symptoms manifest in the week after receiving a Xolair injection, it is essential to seek medical treatment.

Xolair may be contraindicated for:

  • Those who are allergic to the ingredients
  • Pregnant or breast-feeding women
  • Individuals with a history of cancer
  • Those with parasitic infections or who are recovering from one

Long-Term Use of Xolair

There is limited research on the long-term use of Xolair for food allergies. However, studies have shown that Xolair is safe for up to five years of use in people with asthma.

In some cases, people develop cancer and circulation problems with long-term Xolair treatment. It is uncertain if Xolair is related to these effects.

More research is needed to determine the long-term impact of Xolair on food allergies.

How Does Xolair Compare to Other Treatment Options?

Treatments for allergies aim to avoid allergens, improve tolerance through training the immune system gradually with time and exposure, and block the immune reaction entirely.[8]

Traditional allergy medications, such as antihistamines and epinephrine, are used to manage allergic reactions after they occur. They do not prevent reactions from happening and are not as effective in treating severe reactions.

Oral immunotherapy (OIT) is a treatment that involves gradual exposure to small amounts of an allergen to increase an individual’s tolerance. While OIT has shown promising results in reducing allergic reactions, it is a time-consuming and potentially risky process. Additionally, OIT does not work for everyone, and it may not be suitable for those with multiple food allergies.

Palforzia is another medication explicitly approved for treating peanut allergy. It comprises a peanut protein extract that helps to desensitize the immune system of those with peanut allergy[9]. Like many oral tolerance-boosting strategies, it works for some individuals and risks causing an allergic reaction in others.

By comparison to these treatment options, Xolair can prevent reactions by diminishing the immune response to the allergen. It does not build tolerance or risk excess exposure, yet it can improve tolerance by curbing free IgE before it binds and produces an immune reaction.

Managing Food Allergies Holistically

While Xolair may be a game-changer for those with food allergies, it is essential to remember that managing food allergies holistically is still crucial. Management involves avoiding allergens, carrying emergency medication, and having a plan for dealing with allergic reactions.

Here are some tips for holistic allergy management:

  • Strict Allergen Avoidance: The most important step is meticulous reading of food labels and identifying all potential allergen sources. This includes being aware of cross-contamination risks in manufacturing and restaurants.
  • Nutritional Balance: Work with a dietitian to ensure your diet remains nutritionally complete while eliminating allergens. This is especially important for children.
  • Gut Health: A healthy microbiome can help to maintain immune tolerance. Early-life loss of gut microbe diversity may promote allergies. Focus on these components[10]:
    • Prebiotics: Fiber-rich foods feed beneficial gut bacteria. Examples include fruits, vegetables, and whole grains.
    • Probiotics: Foods like yogurt, kimchi, sauerkraut, and supplements can introduce beneficial bacteria.
  • Reduce Inflammation: An anti-inflammatory diet may be helpful to keep the immune system less reactive, improve gut health, and lower the risk of allergy[11]. Focus on:
    • Plenty of fruits and vegetables: These contain abundant antioxidants and beneficial compounds that may assist with lowering immune reactivity.
    • Omega-3 Fatty Acids: These are found in oily fish (salmon, mackerel), flaxseeds, and chia seeds.
    • Minimize processed foods, especially those high in unhealthy fats and sugars.
  • Potential Supplemental Support: While more research is needed to confirm their benefits, the following supplements may help lessen immune responses to allergies and improve tolerance.*
    • Quercetin: A natural anti-inflammatory and antihistamine found in apples, onions, and berries. Supplements are also available[12].
    • Vitamin D: Vitamin D deficiency is a prevalent problem that may contribute to allergy. Supplementation may support immune function[13]. Check with your doctor for appropriate levels and supplementation needs.
    • Digestive Enzymes: These can help some individuals better break down foods, potentially reducing reactions if the allergy isn't severe[14]. More research is needed to confirm their efficacy in humans[15].

*These supplements are not meant to replace allergy medications, treatments, or medical advice. More research is needed to confirm their effectiveness in the context of allergies. Consult with a nutritionist or qualified expert before starting any new supplement.

Additional Considerations

  • Open Communication: Alert restaurants, schools, and social circles to ensure a safe environment.
  • Emergency Plan: An emergency plan with epinephrine (if prescribed) for severe allergies is vital.
  • Stress Management: Stress can worsen allergy symptoms for some[16]. Mindful practices like meditation or yoga can be helpful.

Holistic approaches are complementary to traditional allergy management, not a replacement. Only stop prescribed medication if your doctor advises you to do so.

Conclusion

The FDA's approval of Xolair for reducing accidental food allergy reactions is a significant development in managing food allergies. It provides a new option for those with multiple food allergies and may help reduce the severity of allergic reactions. However, it is essential to remember that Xolair is not a cure for food allergies and does not eliminate the need for avoiding allergens. Managing food allergies holistically and collaborating with a healthcare provider for an individualized treatment plan is crucial.

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Sources:

  • [1] https://www.frontiersin.org/articles/10.3389/fcimb.2018.00376/full
  • [2] https://www.ncbi.nlm.nih.gov/books/NBK545183/
  • [3] https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-help-reduce-allergic-reactions-multiple-foods-after-accidental
  • [4] https://www.xolair.com/
  • [5] https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf
  • [6] https://www.nih.gov/news-events/news-releases/antibody-reduces-allergic-reactions-multiple-foods-nih-clinical-trial
  • [7] https://www.xolair.com/important-safety-information.html
  • [8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8974751/
  • [9] https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children
  • [10] https://www.nccih.nih.gov/health/probiotics-what-you-need-to-know
  • [11] https://onlinelibrary.wiley.com/doi/10.1111/all.15687
  • [12]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6273625/
  • [13]https://link.springer.com/article/10.1007/s11882-011-0230-7
  • [14] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5467726/
  • [15] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996948/
  • [16]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4120667/

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