Allergy Year in Review: 2024

During 2024, the world of allergy medicine was greatly expanded by new clinical trial data, updates to immunotherapy guidelines, and several new US Food and Drug Administration (FDA) approvals that promise to shift the landscape of allergy management.

Indeed, allergists need only turn to such approvals as those of epinephrine nasal spray (neffy) and omalizumab (Xolair) to see how dramatic the recent changes in the allergy management landscape have become. Other significant developments in 2024 have been more understated, such as new data on allergens in infant skincare products and on new guidelines for insurance.

These events and many others have made 2024 a memorable year in allergy news. Here, the HCPLive editorial team provides a list of some of the year’s highlights:

Notable FDA Approvals

FDA Approves Omalizumab as First Treatment of 1 or More Food Allergies for Children, Adults

Omalizumab (Xolair) was approved by the FDA in February for treatment of allergic reactions such as anaphylaxis that occur due to exposure to 1 or more food allergens. It was specifically approved for adults and children aged 1 year and older who also have immunoglobulin E (IgE)-mediated food allergies, and it represents the first and only medication approved for those with 1 or more IgE-mediated allergies.

"The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children's birthday parties, school lunches, and holiday dinners with friends and family," Kenneth Mendez, CEO and president of the Asthma and Allergy Foundation of America (AAFA), said in a statement. "Given the growing prevalence of food allergies, this news offers hope to the many children and adults who may benefit from a new way to help manage their food allergies."

Fluticasone Propionate (XHANCE) Receives FDA Approval for Chronic Rhinosinusitis

In another 2024 FDA announcement, the agency approved Optinose’s fluticasone propionate nasal spray (XHANCE) for individuals with chronic rhinosinusitis without nasal polyps. It was indicated for patients aged 18 years and older.

The approval decision by FDA officials has allowed fluticasone propionate nasal spray to become the first and only treatment to receive such an indication. The approval itself was based upon findings from a pair of studies within the phase 3 ReOpen clinical trial program.

“While we often resort to using nasal steroid sprays in this patient population, they have never been shown to be effective in large placebo-controlled clinical studies,” Rick Chandra, MD, professor of Otolaryngology-Head and Neck Surgery at Vanderbilt University, said in a statement. “[Fluticasone propionate nasal spray], which uses the Exhalation Delivery System to enable delivery of an established topical steroid to the areas of the nasal cavity and sinuses we know to be extensively inflamed, is now proven to be effective in treating our CRS patients both with and without nasal polyps.”

FDA Approves Epinephrine Nasal Spray for Emergency Treatment of Allergic Reactions

One of the most notable 2024 approvals by the FDA within the allergy space was the August approval of epinephrine nasal spray (neffy) for adults and children with severe allergies requiring emergency treatment of severe allergic reactions, including life-threatening anaphylaxis.

The nasal spray is administered by users through a single-dose into 1 nostril, although there may be a second dose within the same nostril provided patients’ symptoms do not subside. This FDA approval represented a milestone as it allowed for the first alternative to injectable epinephrine, under the domain of products like the EpiPen.

The epinephrine spray’s approval decision by FDA officials had been supported by 4 clinical studies that assessed a total of 175 healthy adult participants. During these analyses, investigators compared the epinephrine levels in the blood of participants after being treated with the nasal spray and other current injectable epinephrine options.

FDA Approves Dupilumab for Adolescents with Chronic Rhinosinusitis with Nasal Polyps

Dupilumab (Dupixent) was also approved in 2024 as an add-on maintenance treatment option for patients in the age range of 12 - 17 years who have chronic rhinosinusitis with nasal polyposis (CRSwNP). The approval of dupilumab also expands the drug’s age range among users following the June 2019 approval for CRSwNP among patients aged 18 years and older.

“We are pleased to bring the well-established efficacy and safety of [dupilumab] to the many children suffering from chronic rhinosinusitis with nasal polyps…” George D. Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal dupilumab inventor, said in a statement. “More than one million patients around the world are now being treated with [dupilumab], from infants to adults, and across multiple diseases exacerbated by type 2 inflammation, from asthma to atopic dermatitis.”

FDA Approves Benralizumab for Eosinophilic Granulomatosis with Polyangiitis

Another approval from 2024 was that of benralizumab for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). The decision by FDA officials was based upon trial results from the phase 3 MANDARA study, comparing benralizumab to the only approved therapy for EGPA at the time which was mepolizumab.

“This approval is great news for patients with EGPA in the US who continue to suffer from debilitating symptoms,” MANDARA investigator Michael Wechsler, MD, MMSc, professor of Medicine and director of The Asthma Institute at National Jewish Health, said in a statement. “Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy.”

Allergy News Highlights

Preservative, Surfactant Allergens Frequently Found in Infant Skincare Products

In a poster presentation at the American Academy of Dermatology (AAD) 2024 Annual Meeting in San Diego, new data demonstrated that allergens linked to risk of allergic contact dermatitis were shown to often be present in the ingredients of the US’s best-selling skincare products marketed toward infants.

The data highlighted some of the most common ingredients, specifically such ingredients as phenoxyethanol and tocopherol, which investigators suggest may induce risk of allergic contact dermatitis. The results were the conclusion of a cross-sectional analysis, during which investigators matched the 10 most popular baby skincare products from the 10 largest US-based retailers with allergens that had been reported within the Core Allergen Series report on common allergens observed in patch testing.

Positive Phase 3 Results Announced for Sublingual Epinephrine Treatment

In another example of notable 2024 allergy news, an announcement was made by Aquestive Therapeutics, Inc., in which it was suggested that sublingual epinephrine (Anaphylm Sublingual Film) for individuals with severe allergic reactions such as anaphylaxis, had met all of its predefined primary and secondary pharmacokinetic endpoints in new phase 3 clinical trials.

“The data from the Anaphylm pivotal study build on the compelling data generated from the prior Anaphylm pilot studies,” David Golden, MD, of Sinai Hospital of Baltimore and Franklin Square Hospital in Baltimore, said in a statement. “These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments.”

New Medical Guidance Provides Insurance Recommendations for Allergen Immunotherapy

In other 2024 news in the allergy field, a new set of guidelines were released by the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI), and the American Academy of Otolaryngic Allergy (AAOA) for insurance companies regarding the necessary requirements for clinicians’ documentation of allergen immunotherapy.

The recommendations by these organizations were crafted within a work group that was begun by the ACAAI and were published in Annals of Allergy, Asthma and Immunology.

“Burdensome and unreasonable requests for documentation regarding these services threaten the ability of allergists/immunologists and otolaryngologists to administer these therapies,” J. Allen Meadows, MD, ACAAI’s executive director of advocacy and government affairs and the lead author, said in a statement. “They also hinder the ability of patients with allergic conditions to obtain relief.”

Infants < 1 Year with Food Allergy Can Safely Eat Low Doses of Causative Food

Another set of trial data worth highlighting from 2024 showed that infants under a year with a food allergy may safely consume lower doses of causative foods. The new data also indicated that parents may need to avoid eliminating causative foods in their infant’s diet as exposure may help infants in the long run.

“The amount of food that can be consumed without triggering allergic symptoms can be confirmed when a patient passes the [low-dose oral food challenge],” wrote investigators, led by Mari Takei, from the department of allergy at NHO Sagamihara National Hospital in Japan. “This strategy also reduces the burden on guardians regarding allergic symptoms caused by contamination."