Welcome to our October research update! Getting involved with research is an important way to impact food allergy treatments, education, and awareness.
This month, we are highlighting news on:
- Estimated timelines for under-the-tongue epinephrine approval
- Clinical results for epinephrine nasal spray
- FDA guidance to improve safe food options for people with food allergy
- Sublingual immunotherapy (SLIT) clinical results for children with peanut allergy
- Possible treatment for EoE in ages 1 to 11
Latest Food Allergy News
Eosinophilic Esophagitis (EoE)
Dupixent® (Dupilumab) sBLA for Treatment of Eosinophilic Esophagitis In Children Aged 1 to 11 Accepted for FDA Priority Review
The Food and Drug Administration (FDA) is reviewing Dupixent (dupilumab) as a possible treatment for children aged 1 to 11 with eosinophilic esophagitis (EoE). Dupixent® is already approved for people aged 12 and older with EoE. The news follows a study that showed Dupixent helped children in this age group achieve and retain remission. While some side effects were noted, they were consistent with the drug's known safety profile. The FDA will aim to make a decision by Jan. 31, 2024.
Aquestive Therapeutics Reaffirms Timeline and Pathway for Anaphylm™ (Epinephrine) Sublingual Film
Aquestive Therapeutics provided an update on their under-the-tongue epinephrine product, called Anaphylm™. In previous studies, Anaphylm was found to be safe and work as effectively as other forms of epinephrine. The company plans to start a clinical trial for the product in late 2023 in hopes of getting treatment approval by the FDA in 2024.
Single and Repeat Dose Clinical Study of neffy® (Epinephrine Nasal Spray) Published in the Journal of Allergy and Clinical Immunology
The results from a study on neffy were recently published in the Journal of Allergy and Clinical Immunology. It is a form of epinephrine that is sprayed into the nose instead of injected. The study found that neffy works as well as or better than other forms of epinephrine in treating severe allergic reactions. It also delivered consistent epinephrine levels similar to injections and provided a stable response to a second dose, unlike traditional injections. The study found neffy to be well-tolerated, with mild side effects like nasal discomfort and headaches. Despite FDA requirements for more studies on neffy®, ARS Pharma aims to launch neffy® in the second half of 2024 if approved.
FDA Draft Guidance Could Result in Safer Food Options for People with Allergies to Sesame, Other Food Allergens
The FDA has released new guidelines to help food makers follow safety rules regarding allergens. Millions of people in the U.S. have food allergies, which can cause severe reactions called anaphylaxis. Recently, sesame was added as a major allergen, meaning it must be clearly labeled in foods. After the law was passed, some companies started adding sesame to their products on purpose. While doing so follows the law, it limits choices for people with food allergies. The FDA wants companies to prevent allergen cross-contact without adding more allergens. The goal is to make food safe for everyone, especially people with food allergies while providing clear and accurate food labels.
Sublingual Immunotherapy May Result in Desensitization and Remission for Peanut-Allergic Children
New research published in The Journal of Allergy and Clinical Immunology shows that peanut sublingual immunotherapy (SLIT) is safe and effective for young children. It may also result in desensitization and remission for kids with peanut allergy. The study involved 50 kids ages 1 to 4 years. Half of the participants received SLIT for peanut, and half received a placebo. After 36 months, children who were desensitized to peanut stopped treatment and were then tested for remission three months later. Overall, 60% of the treated kids experienced desensitization and 48% experienced remission three months after stopping treatment. No placebo kids outgrew their allergy. While more research is needed, early peanut SLIT appears promising for managing peanut allergies in children.
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