Welcome to our March research update! Getting involved with research is an important way to impact food allergy treatments, education, and awareness.

This month, we are highlighting research news on:

• Approval of nasal epinephrine spray for young children
• Peanut oral immunotherapy (OIT) for toddlers

Note: The links below will take you to external websites.

Latest Food Allergy News

Anaphylaxis

FDA Approves neffy® 1 mg Epinephrine Nasal Spray for Children 4 and Older Who Weigh 33 to 66 Pounds
The Food and Drug Administration (FDA) has approved neffy® 1 mg, a needle-free epinephrine nasal spray, for children aged 4 and older who weigh 33 to 66 pounds. The approval is based on data from clinical trials that show neffy works as effectively as injection-based epinephrine.

The data show neffy is also safe to use, with clinical trial participants reporting mostly mild and temporary side effects. Other studies show the treatment is also easy to use. Human factor studies showed that children as young as 10 could use neffy correctly by following instructions. Untrained caregivers, like babysitters or teachers, could also use it effectively.

The nasal spray has a 24-month shelf life, handles high temperatures, and can be thawed if accidentally frozen. The newly approved 1 mg dose is expected to be available in the U.S. by May 2025.

Food Allergy

FDA Agrees Application for Viaskin Peanut Patch Can Move Forward
The FDA has agreed DBV Technologies can move forward with a Biologics License Application (BLA) for their Viaskin® Peanut Patch in 4 to 7 year olds. This decision is based on existing safety data and removes the need for an extra safety study. This will allow DBV to submit the application in early 2026 and may move approval up by 1 year. If approved, the patch can be another treatment option for children with peanut allergies.  

Palforzia Launches Its Approved Peanut Allergy OIT for Toddlers
Palforzia is now available in the U.S. for toddlers ages 1 to 3 years old. Palforzia is an oral immunotherapy (OIT) for peanut allergies that helps protect from accidental exposure. Palforzia was first approved in 2020 for children aged 4 to 17. Its approval expanded to younger kids in July 2024.

The latest approval is based on data from clinical trials that looked at 146 children aged 1 to 3 with peanut allergies. Of those, 98 took Palforzia and 48 received a placebo (non-treatment) for 1 year. By the end of the study, 74% of children on Palforzia could safely eat about 2 peanuts, compared to just 6% in the placebo group. 61% of Palforzia-treated kids could tolerate up to 8 peanuts, while only 2% of the placebo group managed the same amount.

The study proved Palforzia was better than non-treatment in helping children with peanut allergies build tolerance. Experts believe this treatment meets an important need for toddlers with peanut allergies, giving parents a safer way to manage accidental exposure.