Food allergies in the news – below are some hot topics!
- In May 2016 the U.S. Food and Drug Administration (FDA) announced changes to the safety labeling for EpiPen®, EpiPen Jr® and other epinephrine auto-injectors.
1. Hold leg firmly during injection
2. Hold the EpiPen® or EpiPen Jr® firmly in place for 3 seconds when injecting
3. See a doctor for signs of infection at the injection site
Here is the link to the FDA’s update.
- You may be eligible for Tax Breaks for Food Allergy and Celiac Special Diets!
- U.S. Updating Rules for Food Manufacturers With Food Allergies in Mind: New rules took effect September 2016. The new rules address cross-contact of allergens and give authority to the FDA to force food allergy recalls.
- A New Allergen Safety Rule To Help Prevent Product Recall
- Common Additive May Be a Cause of Food Allergy
- Study: Adolescents with More Support Take Fewer Food Allergy Risks
- Swimming Offers 3 Key Benefits for Children with Asthma
- Link Between Infant Feeding and Food Allergies: Switching between breastfeeding, pumped breast milk, and formula increases the risk of food allergies compared with breastfeeding alone. This study also confirmed that when a parent has food allergies, the child has a higher risk of developing them.
- Secondhand Smoke Increases Food Allergy Risk: Children exposed to secondhand smoke as infants have a higher risk of developing egg and peanut allergies than children whose parents did not smoke.
- New International Guidelines for FPIES: Guidelines have been developed for the diagnosis and management of Food Protein-Induced Enterocolitis Syndrome (FPIES), a non-IgE gastrointestinal food allergy that manifests as profuse vomiting, often with diarrhea, acute dehydration, and lethargy. The most common triggers are milk and soy, but any food can cause an FPIES reaction.
- Update on epinephrine auto-injectors:
- Kaléo, a privately-held pharmaceutical company, brough the AUVI-Q® (epinephrine injection, USP) Auto-injector back to the market in February 2017. They announced AUVI-Q AffordAbility, a first-of-its-kind access program for AUVI-Q. Through this new program, patients with commercial insurance, even those with high-deductible plans, will have an out-of-pocket cost of $0. For patients who do not have government or commercial insurance, and have a household income of less than $100,000, AUVI-Q will be available free of charge. In addition, the cash price for AUVI-Q is $360 and will be available to those patients without government or commercial insurance. Each AUVI-Q prescription includes two Auto-injectors and one Trainer for AUVI-Q. For more information on AUVI-Q®, click here.
- Auto-Injector Choices for 2017: Auvi-Q Returns, Generics Available Across U.S.
- CVS Now Offering Generic Version of Adrenaclick Epinephrine Auto-Injector
- Recap: Four Auto-Injectors on the Horizon
- Advances in food allergy therapies and more:
- Study: New Gene Therapy Protects Against Anaphylaxis from Peanut Allergy
- Study: Diet Rich in Fiber Helped Lessen Food Allergy Reactions in Mice
- Peanut patch shows sustained response in extension trial
- Peanut Patch Shows Continued Promise: After three years of immunotherapy using a patch, 83.3% of children showed improvement in the amount of peanut protein they could tolerate (compared with 53.6% after the first year).
- Other Food Allergy Immunotherapy Advances: Sublingual immunotherapy (under the tongue) for peanut allergy is improving tolerance to peanut, and oral immunotherapy for walnut and wheat are showing promise.
- Adult Peanut Allergy: Therapy Cleared to Begin Phase IIa Trials
- FDA approves Odactra for house dust mite allergies
Previous news topics posted on this page:
June 21, 2016:
- The FDA announced changes to the labeling for epinephrine auto-injectors to help families use the medication effectively and reduce the risk of injury.
- For EpiPen® and EpiPen Jr® auto-injectors only, hold the EpiPen firmly in place for three seconds when you inject. The labeling change says this is enough time to keep the auto-injector in the outer thigh. This is a reduction from a previous time of ten seconds.
- For all epinephrine auto-injectors, hold the patient’s leg and keep the leg steady while you inject the epinephrine.
- Read the FDA label update here.
- See FARE’s blog about this topic here.
- Kellogg has decided to add peanut flour to their Keebler crackers which were previously peanut free. See more info here.
- In Fall 2015, Sanofi returned all U.S. and Canadian rights to Kaléo, the developer of Auvi-Q. Kaléo’s CEO says they are planning their relaunch for bringing Auvi-Q back to market. See more info here.
- Check out allergystopnow.com for another potential epinephrine device that is more compact than Mylan’s EpiPen®.
- Food allergy legal matters:
- To help restore access to school nurses in the most needy school districts, the Nurses for Under-Resourced Schools Everywhere Act or NURSE Act has been introduced in the Senate by Senator Jon Tester of Montana. The act allows schools and state agencies to apply for federal grants to be used to hire more nurses and improve student health. The grants will be administered by The US Department of Education. See more info here.
- Bipartisan bill to the Senate called S. 1972, the Airline Access to Emergency Epinephrine Act, did not pass as hoped. The bill would have required airlines: to carry epinephrine auto-injectors on every U.S. flight; to train staff on how to use them and on anaphylaxis symptoms; and it called for a special report to Congress on airline policies for food-allergic passengers. See more info here.
- A new law in Texas, HB 1550, passed to allow pharmacists to administer epinephrine to a patient on their premises. The new law can help pharmacists save lives in emergency situations without fearing repercussions. See more info here.
- Research studies on food allergy therapies and more:
- DBV Technologies’ Phase II milk patch and Phase III peanut patch clinical trials are underway and showing promising results. The Viaskin peanut patch is expected to be approved by the FDA in 2018. See more info here. If you are interested in participating in any of these trials, visit clinicaltrials.gov for eligibility criteria, contact information, and the list of recruiting sites: peanut, milk patch for allergy, milk patch for EOE.
- Researchers from the Mayo Clinic investigated how much peanut trace could be found in public environments and presented their findings at this year’s annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). See more information here and here.
- A new study funded by FARE and the National Institute of Allergy and Infectious Diseases (NIAID) points to the lasting effect of introducing peanuts early in life, according to the results of the LEAP-On Study published in the New England Journal of Medicine. The continuation of last year’s LEAP Study, these findings showed that even after abstaining from peanuts for a full year, children at high risk for developing peanut allergy who had previously consumed peanuts regularly up to age 5 continued to be tolerant. See here for a summary of the proposed peanut allergy prevention guidelines.
- Innovate Biopharmaceuticals Inc. has licensed all of Alba Therapeutics’ assets related to larazotide acetate for the treatment of celiac disease and will be initiating Phase III clinical trials in late 2016. The compound INN-202 has received “fast-track” status from the FDA and may potentially become the first medicine for treating celiac disease. See more info here.
- Intrommune Therapeutics has been testing a biopharmaceutical food allergy treatment using oral mucosal immunotherapy (OMIT). The treatment, which adds an element to toothpaste, has successfully undergone proof-of-concept study, meaning they can move forward with testing OMIT with their peanut allergy product (INT-301). See more info here.
- Researchers at National Jewish are testing the combination of two antihistamines (H1 antihistamine loratadine plus an experimental H4 receptor antagonist JNJ7777120) in peanut-sensitive mice to suppress the gastrointestinal symptoms of anaphylaxis. See more info here.
- The Academy of Immunology and Microbiology says their research shows that a certain probiotic called Bifidobacterium longum KACC 91563 (BLK for short) can reduce food allergy symptoms and effects. See more info here.
- Check out this special report on the top studies from the American Academy of Allergy Asthma and Immunology meeting held in March 2016.
November 20, 2015:
- Sanofi’s Auvi-Q Recall: Sanofi US is voluntarily recalling all Auvi-Q epinephrine auto-injectors on the market. The products have been found to potentially have inaccurate dosage delivery. Sanofi US is notifying its distributors and customers who include doctors, pharmacies, wholesalers and other customers in the supply chain by letter, fax, email and phone calls and is arranging for return and reimbursement of all recalled products. Customers with questions regarding this recall can visit www.auvi-q.com or call 877-319-8963 or 866-726-6340. Sanofi US previously noted that, due to a high volume of calls, callers may have received a message that the line is down. They are asking consumers to please call back and try both numbers if this happens. Sanofi US is recommending consumers visit the website for more information and has also posted additional information about common questions here.
- Airline Access to Emergency Epinephrine Act of 2015 (S. 1972): U.S. Sens. Mark Kirk (R-IL) and Jeanne Shaheen (D-NH) introduced the Airline Access to Emergency Epinephrine Act (S. 1972) in August 2015. Intended to improve airline travel for passengers with food allergies, the bill requires that airlines stock epinephrine auto-injectors and train crew members when and how to administer them. Importantly, the bill also would require a report to Congress by the General Accountability Office on current airline policies regarding food allergy accommodation and the incidence of in-flight allergic reactions. This is important so that we can benchmark current practices and have data that may inform future recommendations. For more information, check out this article. Please visit the FARE Advocacy Action center to send letters to your senators asking that they co-sponsor S. 1972, especially if you live in Alaska, Colorado, Florida, Georgia, Hawaii, Minnesota, Missouri, Nevada, New Jersey, North Carolina, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington or Wisconsin.
- Epinephrine Access and Emergency Treatment Act: the bill (designated S-2884 and A-4094) would allow individuals who have completed an approved training course to maintain and administer epinephrine auto-injectors for emergency use, and employers of those individuals to obtain stock epinephrine for use by them. The legislation also provides the necessary “Good Samaritan” provisions to shield all involved from liability when epinephrine is administered in good faith during an anaphylactic emergency. Though the legislation would provide for access to stock epinephrine auto-injectors in restaurants, theaters, amusement parks, camps, and other public places, it would not mandate that such places provide them. Note that Colorado is one of the 17 current states that have passed legislation that permits, but does not require, various public venues, referred to as entities, to stock undesignated epinephrine for use in case of an emergency (Article 47 of Title 25, C.R.S.).
- Peanut Patch moving to Phase 3 clinical trials: DBV Technologies recently announced new topline findings that support the efficacy, compliance and safety profile of Viaskin Peanut®, also known as the peanut patch. DBV reports that no serious adverse events or epinephrine use resulted due to the peanut patch during the first 12 months. 12 additional months of therapy increased the number of patients benefiting from treatment. See the full press release here. DBV Technologies remains on track to start its Phase 3 trial in peanut allergic children (ages 4 to 11), the PEPITES (Peanut EPIT Efficacy and Safety study) study, by the end of 2015.
- New FDA requirements for food safety elevate allergen controls: New regulations released in September 2015 from the Food and Drug Administration (FDA) now include several provisions related to food “allergen cross-contact” that elevate the importance of allergen management in the manufacturing environment. The new additions to the “Current Good Manufacturing Practices,” signal increased recognition by the FDA that the presence of unintended food allergens is a problem that needs to be avoided and addressed by food companies. See more information here.
- Lobbying to add sesame to list of top allergens: Senators Chris Murphy (CT), Richard Blumenthal (CT) and Ed Markey (MA) are encouraging the Food and Drug Administration (FDA) to expand the Food Allergen Labeling and Consumer Protection Act to include sesame. If successful, this would add sesame to the list of major allergens that are required to be labeled by the FDA. The FDA has continued to deliberate about this matter.
- Research exploring the role of probiotics in food allergies: A team of researchers from the U.S. and Italy has published a new study suggesting that a probiotic formula could modify cow’s milk allergy by altering the gut bacteria of infants. The study, published in The ISME Journal by scientists at University of Chicago, Argonne National Laboratory and the University of Naples Federico II, Italy, found that the gut bacteria of infants who had developed tolerance to cow’s milk after treatment with a probiotic formula showed significant differences from those who still had a milk allergy. See the press release here.
August 29, 2015:
- Senate bill seeks safer air travel for the food allergic: U.S. Sens. Mark Kirk (R-IL) and Jeanne Shaheen (D-NH) introduced the Airline Access to Emergency Epinephrine Act (S. 1972), bipartisan legislation that would lead to a comprehensive study of airline policies and require airlines to carry epinephrine auto-injectors for use in allergic emergencies. The bill also directs the Federal Aviation Administration and individual airlines to clarify that the 1:1,000 epinephrine ampules that are currently included in airline emergency medical kits are intended to be used for the treatment of anaphylaxis and calls for crew members to be trained on how to recognize the symptoms of an acute allergic reaction and how to administer auto-injectable epinephrine. For more information, check out this article. Please visit the FARE Advocacy Action center to send letters to your senators asking that they co-sponsor S. 1972.
- Preventive Peanuts: Data from the Learning Early About Peanut (LEAP) study shows that early introduction of peanuts may offer protection from the development of peanut allergies. Here is the link to the New England Journal of Medicine article. Leading professional allergy organizations from across the globe recently released interim guidance for healthcare providers based on the LEAP study – read more here.
- Peanut Patch (brand name VIASKIN®) moving to Phase 3 clinical trials: Researchers used a patch to dose peanut-allergic children with small amounts of peanut protein for one year. New analyses show that 50 percent of children were able to achieve a dose of at least 300 mg of peanut protein after 12 months of treatment versus 12.9 percent in the placebo arm. The threshold dose of 300 mg peanut protein is clinically relevant, as reaching this level significantly reduces the risk of allergic reactions against potential peanut traces in foods. DBV Technologies remains on track to start its Phase 3 trial in peanut allergic children, the PEPITES (Peanut EPIT Efficacy and Safety study) study, in late 2015.
- Peanut OIT gains fast track status with the FDA: The FDA has recognized Aimmune Therapeutics’ AR101 peanut desensitization treatment as a “breakthrough therapy” – a designation that will speed up development and testing of the oral immunotherapy (OIT) treatment. For more information, check out this press release and this article.
- New drug for allergic asthma may hold promise: Preliminary results show that a drug undergoing testing, SB010, may significantly improve lung function in asthmatic patients. Researchers plan to conduct additional clinical trails to further evaluate clinical benefits.
- Egg yolk-based therapy may help tame gluten: antibodies found in chicken eggs hold promise for treating celiac disease via antibodies in egg yolks that bind with gluten “to neutralize it.” A new drug is expected to launch in 2018. Check out this article.
- We want a cure campaign: End Allergies Together (EAT) has announced a campaign to raise awareness and support for a cure for food allergies, based on a national grassroots effort. Read the article here.
- Stock epinephrine is going public: “Stock epi” is rapidly moving beyond the school grounds and out to public venues, from theme parks, restaurants and sports arenas to daycare centers, and other places. 16 states have now passed “entity laws”, legislation that permits venues to maintain an auto-injector, with the intention of reducing the time it takes to get lifesaving epinephrine to a person having a sudden anaphylactic reaction. See more information here.
Before August 29, 2015:
- Early Oral Therapy for Peanut: Results from a preliminary study on oral immunotherapy for peanut allergy showed that early treatment of preschoolers could significantly decrease allergic reactions.
- Favorable Flu Vaccine News: Researchers found that a “live attenuated influenza vaccine” (LAIV) – a flu vaccine administered through the nose – may be safe for children with egg allergy and/or well-controlled asthma.
- Probiotics and peanuts: Probiotics and OIT prove a promising combo for peanut allergy. Here is the link to the Journal of Allergy and Clinical Immunology article.
- Chinese herbal food allergy treatment: Chinese herbal formula (FAHF-2) is being studied in clinical trials.
- A common class of gut bacteria has the potential to prevent and even treat food allergies, according to a groundbreaking study published in August in the Proceedings of the National Academy of Sciences.
- Epinephrine Stocked by Schools Saves Lives: An EpiPen4Schools survey found that 49 percent of anaphylaxis events at school treated with an epinephrine auto-injector were treated with the school’s stock supply. In addition, 22 percent of students who had an anaphylactic event at school had no known allergies.