US Allergy Immunotherapy News

Omalizumab Shows Superiority to Oral Immunotherapy for Food Allergy

New research presented at the 2025 AAAAI / WAO Joint Congress indicates that omalizumab, an injectable drug recently approved by the FDA for food allergies, demonstrates better outcomes and fewer adverse effects compared to oral immunotherapy (OIT). The study found that 36% of participants receiving omalizumab could tolerate a significant amount of multiple food allergens, compared to only 19% in the OIT group. This difference was largely attributed to higher rates of allergic reactions and treatment discontinuation in the OIT group. A subsequent phase of the study also suggests that some patients may be able to introduce allergenic foods into their diets after stopping omalizumab.

Palforzia® Expands Availability for Younger Peanut Allergy Patients

Stallergenes Greer announced the US launch of Palforzia® for peanut-allergic toddlers aged 1 through 3 years. Palforzia® is the first FDA-approved oral immunotherapy for peanut allergy and is now available for patients aged 1 to 17. Recent studies highlighted a critical therapeutic window in younger peanut-allergic children, where early intervention with Palforzia® can help prevent the progression of sensitization. The FDA's expanded approval was based on the positive results of the Phase 3 POSEIDON study.

NIH Study Shows Promise for Peanut Oral Immunotherapy in High-Threshold Allergy

A National Institutes of Health (NIH)-sponsored trial demonstrated that a home-based peanut oral immunotherapy approach was successful for children with a high threshold for peanut allergy (those who could already tolerate at least half a peanut). The study found that 100% of children in the peanut-ingestion group could tolerate three tablespoons of peanut butter after about 18 months of gradually increasing doses. This simple treatment strategy could offer a solution for a significant portion of peanut-allergic children who were previously ineligible for OIT trials.

US Allergy Immunotherapy Market Trends

The US allergy immunotherapy market is experiencing substantial growth, driven by the increasing prevalence of allergies and a rising awareness of immunotherapy as a long-term treatment solution. Market projections estimate a significant expansion in the coming years.

Key Trends:

• Rising Prevalence of Allergies: The increasing incidence of environmental and food allergies is a primary driver for market growth.
• Growing Awareness: Increased public and physician awareness of the long-term benefits of allergy immunotherapy is boosting demand.
• Technological Advancements: Innovations in diagnostic techniques and the development of personalized allergen vaccines are contributing to market expansion.
• Sublingual Immunotherapy (SLIT) Growth: The adoption of SLIT tablets is increasing due to their convenience and safety profile.
• Focus on Personalized Medicine: The demand for tailored immunotherapy treatments based on individual patient profiles is rising.
• Combination Therapies: Combining immunotherapy with biologics like omalizumab is an emerging trend to enhance treatment efficacy.

The US market is expected to remain a leader in North America due to the high prevalence of allergies and the availability of advanced treatment options. Subcutaneous immunotherapy (SCIT) currently holds a significant market share, recognized as the gold standard for many allergies, but SLIT is anticipated to be the fastest-growing segment.

Advances in Allergy Immunotherapy

Key Advances:

• Recombinant Allergens and Peptide Immunotherapy: These offer more precise and potentially safer treatment options by using specific parts of allergens to induce tolerance.
• Novel Delivery Routes: Research into alternative administration methods like epicutaneous immunotherapy (EPIT) and intralymphatic immunotherapy (ILIT) aims to improve safety and efficacy.
• Adjuvants: The use of adjuvants, such as TLR agonists, is being explored to enhance the immune response to immunotherapy.
• Oral Immunotherapy (OIT) for Food Allergies: The approval of OIT for peanut allergy marks a significant step forward in treating food allergies, with ongoing research for other allergens.
• Biologics Integration: Combining biologics like omalizumab with traditional immunotherapy shows promise for patients with severe or multi-food allergies.
• Personalized Immunotherapy: Advances in diagnostics allow for the development of more tailored immunotherapy approaches based on individual allergen profiles and immune responses.