The manufacturers of most epinephrine options offer U.S. savings programs and patient assistance programs.

Epinephrine is the only treatment for a severe allergic reaction known as anaphylaxis [anna-fih-LACK-sis]. It is only available through a prescription by your doctor. Most prescriptions come with 2 doses. Epinephrine is most commonly prescribed in easy-to-use options, such as auto-injectors and nasal spray.

People with food allergies should have epinephrine with them at all times. For children, this might mean that you need extra epinephrine doses. For example, your child may need to keep epinephrine at school, as well as some at after-school care. And you may want epinephrine that stays at home or goes with you when you leave the house.

Here are savings offers for epinephrine options, as well as other ideas that may help you save money on drug costs. Your final copay, if any, may vary depending on your insurance plan and the deductibles for your family. Talk with your doctor about which epinephrine option is right for your family.

Savings Programs for Epinephrine Devices

• AUVI-Q^® – AUVI-Q has 2 assistance programs. If you have commercial insurance (such as through your job or HealthCare.gov) that covers AUVI-Q, you may be able to get AUVI-Q for $35 or less. If your insurance doesn’t cover it or if you have a high-deductible plan, you’ll pay no more than $150. Once you meet your deductible, you may be able to get AUVI-Q for $35.
  
  If you don’t have commercial insurance or are on Medicaid may be able to get AUVI-Q for no cost through the Kaléo Patient Assistance Program. Call 502-213-7601 for questions (9 a.m. – 5 p.m. ET, Monday-Friday).
  
  
  
• EpiPen^® and EpiPen Jr^® – Use The EPIPEN^® Savings Card^® to save up to $300 on your out-of-pocket cost per EPIPEN 2-PACK® and/or EPIPEN JR 2-PACK® carton per prescription refill (up to 3 cartons per prescription) and can be used for 6 cartons per calendar year. If you have questions, call 1-800-657-7613 (8 a.m.-8 p.m. ET, Monday-Friday). VIATRIS™ also has a patient assistance program for EPIPEN® Auto-Injector and its authorized generic.
  
  
  
• Authorized Generic of EpiPen^® and EpiPen Jr^® (Epinephrine Injection, USP) Auto-Injectors – Use the Epinephrine Injection, USP Auto-Injector Savings Card to save up to $25 on your out-of-pocket costs per generic 2-pack. It can be redeemed for up to 3 cartons per calendar year. If you have questions, call 1-800-657-7613 (8 a.m.-8 p.m. ET, Monday-Friday). VIATRIS™ also has a patient assistance program.For more information, call 888-417-5782 (8 a.m.-5 p.m. CST, Monday-Friday).
  
  
  
• Epinephrine Injection USP Auto-Injector, Generic from Teva Pharmaceuticals Industries – If you have commercial insurance may save up to $30 per carton, up to 3 cartons per prescription. If you have any questions, call 1-844-248-7949.
  
  
  
• Authorized Generic of Adrenaclick® Epinephrine Auto-Injector – If you have commercial insurance, you may get up to $10 off per pack. If you have any questions, call 330-757- 8402.
  
  CVS Health sells these generic epinephrine auto-injectors at all CVS Pharmacy locations. Find a CVS location near you.
  
  
  
• neffy® Epinephrine Nasal Spray – If you have commercial insurance, you can pay $25 for each filled prescription of 2 devices. If you don’t have insurance coverage, your plan doesn’t cover neffy, or if you have a high-deductible plan, you can pay a cash price of $199 for 2 doses of neffy using BlinkRx or GoodRX.
  
  The ARS Pharma Patient Assistance Program (PAP), neffyconnect™, may provide neffy at no cost if you:
  • Have a valid prescription for neffy
  • Are a resident of the U.S, Puerto Rico, or the U.S. Virgin Islands
  • Don’t have insurance or you have government or commercial insurance that doesn’t cover neffy
  • Meet certain income criteria
    
    

• If you have any questions, call 1-877-696-3339.

Other Possible Ways to Save Money

• Change insurance plans – If you are privately insured through work, think about a different plan during open enrollment. If your family’s income is below a certain level, you might be able to get Medicaid and/or your children might qualify under the Children’s Health Insurance Program (CHIP). This depends on your state. Visit HealthCare.gov or your state’s health insurance site.

• Switch to the “preferred” device for your plan – If you have prescription benefits, you may save on copays by using the epinephrine option that is on the insurance “preferred” list on your plan’s formulary (list of covered medicines).

• Use mail order – If you have prescription benefits, look into your plan’s mail order pharmacy options. This may give you a lower price or provide more 2-packs of medicine for the same price. Many mail order prescription plans cover with a 3 month’s supply of medicine for the cost of 2 month’s copay.

• Talk with your doctor – If you have insurance, talk with your doctor. Sometimes they can write the prescription so you can get more sets of medicine for 1 copay. Typically, a 2-pack of epinephrine auto-injectors is considered a 30-day supply under your prescription plan. A doctor might write the prescription for 6 auto-injectors (3 packs of 2) to be filled at once. This could then be filled through the mail order pharmacy, as described above.

• Shop around – Call around to different pharmacies. Prices can vary, especially between large chain pharmacies and smaller independent pharmacies. Be aware that the pharmacies at club stores such as Costco and Sam’s Club are generally available to non-members too.

• Check with your local children’s hospital – This option may work if your child sees doctors at a major children’s hospital. Ask if they have any grants or patient assistance programs that can help pay for your child’s prescription.

• Talk with your employer – If you have medical insurance through an employer, contact your human resources department. Explain that your insurance will not cover a life-saving medicine for you or your child. If you have a generous employer, they may try to help you.
  
  

Updated January 2025

Los Angeles and the surrounding areas are being impacted by devastating wildfires. Natural disasters like wildfires can leave families without power, make it harder to get medicines and allergy-friendly food, or even destroy their homes. Because of the widespread destruction caused by these fires, the situation is dire for many families. Many more may have to evacuate as the situation changes.

How Wildfires Impact Families Managing Food Allergies

Food provided by shelters during an emergency may not be safe for kids with food allergies. Even if the ingredients are safe, there may be the potential for cross-contact with their food allergens. This makes access to safe allergy-friendly foods essential in times of emergency.

Access to lifesaving medicine like epinephrine and emergency care can also be limited during and after natural disasters.

If you or your child also have asthma or other allergic conditions, the situation can get more complicated. Wildfire smoke impacts air quality, worsening asthma symptoms. Children and people with respiratory diseases like asthma are at high risk for asthma episodes when air quality is poor.

Relief Resources

If you or someone you know is impacted by the wildfires in California, here are resources that may help:

Safety alerts:

• Evacuation map
• Fire map
• Emergency alerts
• Fires and food safety
• Keep your food safe during emergencies

Food banks and free meals:

Access to allergy-friendly options may be limited at this time.

• World Central Kitchen (WCK)
• Hollywood Food Coalition
• FOODiversity - partnering with food banks to deliver food, including allergy-friendly foods, to families in need
• Securing Safe Food - non-profit supplying allergy-friendly foods to food banks and food pantries in the LA area.
  
  Food pantries are located at:
  • All Peoples Community Center (offering food to all people affected by the wildfires): 822 E. 20th Street, Los Angeles, CA 90011.
  • Children’s Hospital Los Angeles Gores Family Allergy Center (offering food to hospital patients): 4650 Sunset Blvd., MS #75, Los Angeles, CA 90027
  
  Additional pantries may be included in the future. If your local LA food pantry does not offer allergy-friendly options, you can let Securing Safe Food know at: hello@securingsafefood.org

• Garry Marshall Theatre in Burbank – offering allergy-friendly and celiac-safe food products – Pickup is on 1/18 ONLY

• Noble Rotisserie Restaurant in Long Beach and Culver City – Offering free meals dedicated free of peanut, tree nut, milk, fish, and shellfish
  
  If you need a meal, contact them via email first at:info@noblerotisserie.com

• Bread SRSLY– offering care packages of gluten-free sourdough
  
  If you are interested, contact them via email first at:hello@breadsrsly.com
  
  

Disaster recovery centers and programs:

• Los Angeles County recovery centers
• Los Angeles County FEMA assistance
• Habitat for Humanity of Greater Los Angeles (ReBUILD LA®) - a long-term emergency response campaign to rebuild homes, relocate to other housing, and provide essential supplies
• Direct Relief – distributing free N95 masks to protect people from wildfire smoke
  
  

Ways to Donate

The following groups are collecting donations for families in need:

• Hollywood Food Coalition – accepting items from their wish lists, including allergy-friendly foods
• Securing Safe Food - non-profit helping to supply allergy-friendly foods to people in need. They are accepting various allergy-friendly food options at their two drop off locations:
  
  

  • All Peoples Community Center: 822 E. 20th Street, Los Angeles, CA 90011.
    ATTN: Capri Downs

  • Children’s Hospital Los Angeles Gores Family Allergy Center: 4650 Sunset Blvd., MS #75 Los Angeles, CA 90027
    ATTN: Tina Lu or Dr. Jonathan Tam

• Habitat for Humanity of Greater Los Angeles (ReBUILD LA®) - looking for volunteers and donations of select home items
• Los Angeles Dream Center – accepting food, personal protective equipment, clothing, household goods, among other items
• It’s Bigger Than Us – accepting clothing, bottled water, hygiene products, books, toys, comfort items, bedding, snacks, baby supplies, among other items
  
  

As the communities impacted by the wildfires recover, the need for supplies will continue. You can help by sending donations to people in need. We will update this blog as we learn more information.

Schools should be places where children can safely learn and grow. But for students with food allergies, asthma, or other allergic conditions, school environments can present unique challenges. From a lack of school nurses to respond to emergencies to a lack of emergency medicines on hand, there’s still work to be done to ensure every child with food allergies has a safe environment for learning.

To address these challenges, the Asthma and Allergy Foundation of America (AAFA) is proud to release the 2025 State Honor Roll of Asthma and Allergy Policies for Schools. This report identifies the states leading the way in creating healthy environments for students with asthma and allergies. (Kids with Food Allergies is a division of AAFA.)

What Is AAFA’s State Honor Roll Report?

The State Honor Roll evaluates and recognizes state laws and policies that address the needs of children with asthma and allergies in schools. The report focuses on 27 core policies critical to student health. States that meet at least 22 of these standards earn a place on the State Honor Roll and states that meet 17-21 standards receive honorable mention.

2025 State Honor Roll and Honorable Mention States

We celebrate Connecticut and the District of Columbia for making the State Honor Roll and their outstanding commitment to protecting students with asthma and allergies. These states are setting an example by putting policies in place that prioritize children’s health and learning environments.

We also recognize the following honorable mention states for making major strides in improving policies that support the health of students with asthma and allergies: California, Delaware, Illinois, Indiana, Maryland, Massachusetts, New Hampshire, New Jersey, New York, and Washington.

How Can Schools Improve?

The report highlights 5 key ways states can improve their school policies:

1. Expand emergency medicine stocking laws.
   States must ensure schools have stock emergency medicines, such as quick-relief asthma inhalers and easy-to-use epinephrine options. They should also have trained staff to give the medicines.
   
   
2. Ensure full-time school nurses.
   Every school needs at least 1 full-time nurse to manage chronic conditions and give immediate care during emergencies.
   
   
3. Adopt comprehensive indoor air quality (IAQ) plans.
   Clean indoor air policies, including proper HVAC maintenance and mold prevention, are essential for student health.
   
   
4. Strengthen tobacco and vaping policies.
   Banning smoking and vaping on all school grounds and functions protects children with asthma and allergies from harmful exposures.
   
   
5. Transition to zero-emission school buses.
   Electric school buses reduce air pollution and help prevent asthma flare-ups caused by diesel emissions.
   
   

Why Do These Policies Matter?

Food allergies affect about 1 in 17 children in the U.S. A severe allergic reaction can occur in seconds. Quick access to epinephrine and trained staff is necessary. But gaps in school policies can put students at risk of anaphylaxis and other emergencies.

The right policies – such as stocking emergency medicines and having allergy management plans – can save lives, reduce anxiety for families, and help children focus on learning.

“Asthma continues to be a leading cause of missed days of school,” said AAFA’s President and CEO, Kenneth Mendez. “This unfortunate reality highlights the urgent need for states to adopt policies that support students with asthma. This report should serve as a call to action for states to advance meaningful policy change in 2025 and beyond.”

Acknowledgments

The 2025 State Honor Roll™ Report is an independent research project of the Asthma and Allergy Foundation of America and made possible by funding support from Amgen, DBV, Kaléo, Pfizer, PhRMA, Sanofi, Regeneron, and Viatris.

FSIS Issues Public Health Alert For Chicken Empanada Products Due To Misbranding And Undeclared Allergen

For Immediate Release

January 8, 2025

Contact Information

Sanjiv Mody
President of Rajbhog Foods
551-222-4700 or sanjivmody@rajbhog.com.

Company Announcement

WASHINGTON, Jan. 8, 2025 – The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is issuing a public health alert for frozen product labeled as Chicken Curry Empanadas due to misbranding and an undeclared allergen. The product labeled as Chicken Curry Empanadas may actually contain Apple Cinnamon Empanadas, which contain milk, a known allergen, that is not declared on the product label. FSIS is issuing this public health alert to ensure that consumers with allergies to milk are aware that this product should not be consumed. A recall was not requested because the affected product is no longer available for purchase.

The frozen empanada products labeled as Chicken Curry Empanadas that may contain Apple Cinnamon Empanada products were produced on November 14, 2024, and packaged on November 20, 2024, and November 21, 2024. The following product is subject to the public health alert [view label]:

• 9.6-oz. cardboard packages labeled as “bettergoods TRADITIONALLY CRAFTED Chicken Curry Empanadas” with “BEST BY: 05/21/26” or “BEST BY: 05/22/26” and “EST. P33967” on the side of the box.

The products bear establishment number “P33967” on the side of the box. These items were shipped to Walmart locations nationwide.

The problem was discovered when the producing establishment notified FSIS that its distributor received four consumer complaints indicating that the apple cinnamon empanada product was packaged inside the chicken curry empanada retail packaging.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an illness should contact a health care provider.

FSIS is concerned that some product may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Members of the media and consumers with questions regarding the public health alert can contact Sanjiv Mody, President of Rajbhog Foods, at 551-222-4700 or sanjivmody@rajbhog.com.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers that need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Frito-Lay Issues Limited Recall on Undeclared Milk in Lay’s Classic Potato Chips Distributed in Oregon and Washington

For Immediate Release

December 18, 2024

Contact Information

Frito-Lay Consumer Relations
1-800-352-4477

Company Announcement

PLANO, Texas – December 16, 2024 – Frito-Lay today issued a recall of a limited number of 13 oz. bags of Lay’s Classic Potato Chips that may contain undeclared milk, after being alerted through a consumer contact. Those with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the recalled product.

The product included in this recall was distributed to certain retail stores and e-commerce distributors in Oregon and Washington. Consumers would have been able to purchase these chips as early as November 3, 2024.

No allergic reactions related to this matter have been reported to date.

No other Lay’s products, flavors, sizes or variety packs are recalled.

The recalled product is in a flexible bag, and the specific information is listed below:

• Lay’s Classic Potato Chips 13 oz. (368.5 grams)
  • UPC: 28400 31041
  • Must have both:
    • “Guaranteed Fresh” date of 11 FEB 2025
    • AND one of the following the Manufacturing Codes:
      • 6462307xx OR 6463307xx

If consumers have an allergy or sensitivity to milk, they should not consume the product and discard it immediately. Frito-Lay has informed the FDA of this action.

Consumers with the product described above can contact Frito-Lay Consumer Relations at 1-800-352-4477 (9 a.m. – 4:30 p.m. CST, Monday-Friday).

Together, we’ve made incredible progress in improving the lives of people with asthma and allergies.

From advocating to prevent accidental deaths from food allergies, to backing groundbreaking research for new treatments. Our top accomplishments include:

Watch on YouTube

Advocating for Access to Life-Saving Food Allergy Medicines

In 2024, KFA advocated for expanding access to life-saving allergy medicines. Additionally, we took bold steps to advance efforts to prevent accidental deaths from food allergies, protecting our loved ones, whether from daycare settings to airplane travel.

KFA supports:

• FAA Reauthorization - The new law started a process to review the contents of emergency medical kits (EMKs) on planes—specifically to ensure that EMKs contain medication to treat anaphylaxis.
• Elijah’s Law - This law will help ensure childcare centers take steps to manage food allergies for the children in their care and keep children with food allergies safe at their care facilities.
• Dillon’s Law - a bipartisan bill that incentivizes states to allow trained people to carry and give epinephrine in an emergency.

Elevating Your Voice in Research

We strengthened connections between patients and groundbreaking research opportunities, ensuring their voices and needs remain central to innovation. In 2024, KFA recruited participants for clinical trials, surveys, focus groups, and other studies led by academic researchers, federal agencies, and drugmakers. KFA also engaged caregivers of kids with food allergies as expert advisors to many of these researchers.

Through engaging our community with research, KFA developed a decision guide for oral immunotherapy (OIT) that people can use to talk to their allergists about OIT as a treatment option. This decision guide was published in medical journals and is now available to all doctors and people with food allergies.

Helping You Manage Food Allergies with Confidence

In 2024, KFA educated people managing food allergies by:

• Providing personalized support to help people manage asthma and allergies by providing resources and support to over 55,000 people on our two online support communities.
• Responding to 1,228 inquiries submitted to AAFA’s Support Center and 268 questions submitted to AAFA’s Ask the Allergist service.
• Serving as a trusted ally for the food allergy community by sharing the latest news and trends, such as emerging treatment options, new allergy-friendly foods, recipes, and recalls through KFA’s Strides newsletter and digital communication channels.
• Offering health education programs on food allergies and related conditions like asthma and eczema.
  • More than 6,000 people attended our educational programs for people who live with or manage allergic conditions.
  • More than 7,500 health care professionals attended our continuing education programs on treating allergic conditions.

MadeGood Granola Bar Voluntary Recall

For Immediate Release

December 8, 2024

Contact Information

madegood@webershandwick.com
855-215-5695

Company Announcement

We are voluntarily recalling certain MadeGood granola bars as a precautionary measure due to a potential safety hazard. There is a very small risk that some of our granola bar products made between January and November 2024 may contain a piece of metal. We have addressed the source of the issue and are conducting the voluntary recall with the knowledge of regulatory authorities. There have been no reports of injury; we’re initiating this recall out of an abundance of caution and commitment to the well-being of our valued customers.

Please check your product codes and return recalled product to the store where it was purchased for a full refund. Kindly review the link below to determine if the MadeGood granola bar products in your pantry are part of the recall.

*Items with a Z after the Best Before Date are excluded from this recall [e.g., 2025 OC 14 Z].

Product - Description - Size - UPC - Best Before Date*

• Chocolate Banana Granola Bars
  • 120g (5 bars)
    • 687456213040
      • 2025 MA 11 up to and including 2026 JA 17
• Chocolate Chip Granola Bars
  • 1.5 kg (63 bars)
    • 10687456216017
      • 2025 OC 13
  • 960g (40 bars)
    • X002CYW2IB
      • 2025 JN 28 up to and including 2025 OC 25
    • 10687456216444
      • 2025 JN 29 up to and including 2025 OC 25
  • 120g (5 bars)
    • 687456213019
      • 2025 MA 09 up to and including
      • 2025 DE 08 and 2025 DE 10;
      • 2025 DE 24;
      • 2025 DE 26; 2026 JA 10; 2026 JA 17; 2026 FE 03
  • 720g (30 bars)
    • X001TO8QCB
      • 2025 AL 19; 2025 JN 08; 2025 AU 02; 2025 AU 03; 2025 AU 22
  • 360g (15 bars)
    • 687456216119
      • 2025 MA 10 up to and including 2026 JA 10 and 2026 FE 03; 2026 MR 24
  • 576g (24 bars)
    • 687456216300
      • 2025 MA 02 up to and including 2026 JA 10
  • 720g (30 bars)
    • 687456217062
      • 2026 FE 21; 2026 FE 22;
• Chocolate Chip Mini Granola Bars
  • 1.08 kg (90 bars)
    • 10687456214532
      • 2025 MA 12 up to and including 2025 AU 05
  • 576g (48 bars)
    • 10687456215973
      • 2025 AU 05 up to and including 2026 JA 30
• Mixed Berry Granola Bars
  • 1.5kg (63 bars)
    • 10687456216024
      • 2025 SE 21
  • 960g (40 bars)
    • X002CYZ8M3
      • 2025 JL 27; 2025 OC 03
    • 10687456216468
      • 2025 JL 27
  • 120g (5 bars)
    • 687456213026
      • 2025 MA 25 up to and including 2025 DE 29
• Cookies & Creme Granola Bars
  • 120g (5 bars)
    • 687456213750
      • 2025 JL 05 up to and including 2026 FE 10
• Strawberry Granola Bars
  • 120g (5 bars)
    • 687456213170
      • 2025 MA 22 up to and including 2025 NO 22 and 2026 JA 19
• Chocolate Drizzled Birthday Cake Granola Bars
  • 120g (5 bars)
    • 687456214139
      • 2025 JA 08 up to and including 2025 AU 31 and 2025 SE 18
  • 720g (30 bars)
    • X002UAC79V
      • 2025 MR 18 up to and including 2025 MA 15
  • 480g (20 bars)
    • 687456215747
      • 2025 FE 05 up to and including 2025 MR 05
  • 360g (15 bars)
    • 687456215822
      • 2025 JL 23; 2025 SE 17; 2025 OC 16
  • 1.34 kg (56 bars)
    • 10687456216932
      • 2025 AU 29; 2025 SE 20
• Chocolate Drizzled Vanilla Granola Bars
  • 120g (5 bars)
    • 687456214122
      • 2025 FE 15 up to and including 2025 NO 13
  • 720g (30 bars)
    • X002VWC1ZD
      • 2025 MR 07; 2025 AL 01; 2025 AL 15; 2025 MA 10
• Chocolate Drizzled Cookie Crumble Granola Bars
  • 120g (5 bars)
    • 687456214146
      • 2025 JA 05 up to and including 2025 SE 14
  • 720g (30 bars)
    • X002VWCL2L
      • 2025 MR 15; 2025 MA 12; 2025 MA 30
• Chocolate Drizzled Granola Bars
  • 720g (30 bars) Variety Pack 720g (30 bars)
    • X002ZQLF4X
      • 2025 FE 15; 2025 MA 10; 2025 MA 30
• MadeGood Variety Pack
  • 35 count
    • X0043RPWYV
      • 2024 DE 06 up to and including 2025 JL 20
  • 7 count
    • X00347PCCN
      • 2025 FE 17; 2025 FE 18; 2025 FE 21

Refunds will be made available at the retailer where MadeGood products were purchased. If you believe you have a product on the list, please click here for more information. If you would like additional support, please call 855-215-5695 between 8am and 5pm EST.

Before a new drug can be approved for a disease or condition, it has to go through a clinical trial. Clinical trials are important because they give us new treatments, such as drugs, devices, or diets.

In February 2024, Xolair® (omalizumab) was approved for food allergies. Before that time, no other medicine to treat food allergies was available. They could only be managed by completely avoiding your food allergens or through oral immunotherapy (OIT).

Xolair’s approval for food allergies was the result of the OUtMATCH clinical trial. The people who volunteered to be part of the trial were important in making this new medicine available to people with food allergies.

Nicole Rogers, Associate Project Director at Rho, a full-service contract research organization, worked on the OUtMATCH trial. She has seen firsthand how clinical trials can lead to big breakthroughs for people with conditions such as food allergies.

Kids with Food Allergies (KFA) spoke with Nicole about the trial, as well as what it’s like to take part in research that can lead to new treatment options.

KFA: Can you give a brief summary of the OUtMATCH clinical trial?

Nicole: OUtMATCH is a clinical trial that had 3 stages, each with different goals but all focused on patients as young as 1 year of age with multiple food allergies. To be eligible [take part], patients had to be determined allergic to peanut and 2 other study-specific foods, which included cashew, milk, egg, hazelnut, walnut, and wheat. This eligibility was based on results of skin prick tests (SPT), immunoglobulin E (IgE) lab values, and oral food challenges (OFC) for each of the of the foods that would be considered their patient-specific foods for the trial.

KFA: What was the experience like for patients and caregivers during the trial?

Nicole: This trial required a huge commitment from patients and their families. As mentioned above, to be eligible, patients had to complete screening visits consisting of blood draws, skin prick tests, and 4 oral food challenges. Once a patient was enrolled, they attended in-clinic injection visits every 2 to 4 weeks for up to 1.5 years through stages 1 and 2, and then completed an additional 1 and 2 years of follow-up in stage 3 depending on when the patient enrolled.

In addition to the in-clinic visits in stage 2, patients also consumed daily home doses of oral immunotherapy (OIT) powder that consisted of either the 3 patient specific allergens mixed together or of an oat placebo powder. Patients and caregivers would complete daily diaries documenting how much of the OIT dose was consumed and listing any dosing symptoms or reactions that occurred along with any medications that were taken as preventative or treatment of a suspected food allergy reaction.

KFA: Even though the study focused on peanut, milk, egg, wheat, cashew, hazelnut, and walnut, how were you able to find out that Xolair would work for all IgE food allergies?

Nicole: Based on the strong results for peanut, which is 1 of the most common and potent food allergens, along with the results for the additional foods tested, the investigators for the OUtMATCH trial were confident that Xolair would be effective against other food allergens that were not tested given that the mechanism of action [how a medicine works in your body] is the same for all foods. With that said, it is important to always consult with your doctor or allergist before taking any medication with the intent of treating or preventing symptoms related to food allergies to ensure that it is the best fit for your situation.

KFA: Why is it important for people with food allergies to participate in clinical trials?

Nicole: This trial has provided a treatment option to protect against accidental exposures to food allergens. However, hopefully, with continued research, there will one day be evidence of a treatment that will have the ability to modify the underlying disease that causes food allergies instead of patients only having protection while receiving therapy.

KFA: What advice would you give a family who is considering having their child participate in a clinical trial for food allergies?

Nicole: Don’t be afraid to ask questions. That is what the clinical site staff are there for, and they are happy to answer them for you. Also, be open about aspects of the proposed trial that will and will not work for you or your family. Enrolling in a trial and being compliant with the treatment and visits are of the utmost importance to ensure a successful trial.

KFA: If a family decides to participate in a food allergy clinical trial, what can they expect? How are concerns, such as anaphylaxis, typically handled?

Nicole: Anaphylaxis is taken very seriously by the investigators and site staff that are conducting clinical trials. The site staff for the OUtMATCH trial were all extensively trained on the signs and symptoms to watch for during treatments that could result in severe allergic reactions, and they had medicines to combat anaphylaxis such as epinephrine readily available.

KFA: What does a successful clinical trial like the OUtMATCH trial mean for the future of food allergy research and treatments?

Nicole: A trial like OUtMATCH gives patients and caregivers a new hope in knowing that there is a treatment that may prevent them from having severe reactions in the case of an accidental exposure to a food allergen. For many patients and families, this was a fear that caused limitations in how they lived their daily lives.

The success of this trial and approval of Xolair helps reduce the fear that comes with food allergies but does not take it away completely so continued research is important to hopefully one day find therapies that not only prevent or treat reactions but instead modify the underlying disease and remove the fear of life-threatening food allergies in patients’ lives completely.

About Nicole Rogers

Nicole Rogers is Associate Project Director at Rho, a full-service contract research organization. She has more than 7 years of clinical research experience with the last 3 years being focused on food allergy. Nicole is passionate about mentoring and developing clinical research skills in all members of her study teams, which she views as a key to setting up clinical studies for success.