After Xolair’s Approval for Food Allergies, Physicians Have Concerns, Survey Finds

Allergists have mixed views about the use of biologics to treat patients with food allergies, according to a survey conducted by researchers at UNC School of Medicine and published in Annals of Allergy, Asthma & Immunology.

Jill A. Fisher, Ph.D.

“My overall takeaway from this study is that clinicians have very strong concerns about the cost of biologics to treat food allergies, but despite these concerns, enthusiasm in the field for their use remains very high,” co-author Jill A. Fisher, Ph.D., professor of social medicine and member of the Center for Bioethics at the UNC School of Medicine, told Managed Healthcare Executive by email. “I think it will be very important to see how clinicians prescribe FDA-approved drugs like omalizumab for food allergy when they see its therapeutic potential but are anxious both about the costs to the healthcare system and about exacerbating existing health disparities in food allergy.”

Researchers found that providers consider the February 2024 approval of the first biologic to reduce food allergies a “turning point” for treatment. But they are concerned about the safety and efficacy of biologics and their potential for inappropriate use and overuse, as well as their cost to patients and the U.S. healthcare system.

Xolair (omalizumab) was approved to reduce allergic reactions, including anaphylaxis, in for adults and children older than 1 year of age with food allergies with IgE-mediated food allergy. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens.

Related: Positive Results for Xolair For Food Allergy Protection. But Will the Protection Last?

Xolair, marketed by Genentech and Novartis, is a monoclonal antibody that binds to immunoglobulin E and blocks IgE from binding to its receptors. It was originally approved in 2003 for the treatment of moderate-to-severe persistent allergic asthma in certain patients. Xolair is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.

An estimated 8% of children in the United States have an allergy to certain foods, with more than 40% of these children being treated in the emergency room, according to the Centers for Disease Control and Prevention. Among adults in the United States, about 6% have a food allergy, according to the CDC.

Researchers from the Annals of Allergy, Asthma & Immunology study conducted 60 interviews with providers from 34 states working either in community practice (53.3%) or academic medical centers (46.7%). The study was conducted between January 2023 and October 2023 and interviews were conducted through telephone or Zoom.

Of those who participated in the survey, about half have prescribed peanut (A hypogaea) allergen powder-dnfp, which is marketed as Palforzia, and 13.3% of respondents had specifically prescribed Xolair or dupilumab off-label to treat food allergies.

Palforzia was approved in January 2020 as an oral immunotherapy for patients from 1 to 17 years of age for the mitigation of allergic reactions from peanuts. Dupilumab is approved as Dupixent to treat several indications that involve inflammation, such as atopic dermatitis, asthma and most recently chronic obstructive pulmonary disease.

The researchers found that community and academic physicians had largely similar views. They indicated that biologics have benefits, including addressing a treatment need, treating comorbid allergic conditions and multiple food allergies.

Physicians who are enthusiastic about biologics see them as another tool for managing allergies, especially for patients with multiple allergic conditions in one treatment. People with food allergies often have other types of allergic conditions. The most common allergic comorbidities reported by patients with food allergies were atopic dermatitis (48%), asthma (46%), and allergic rhinitis (39%), according to one study released earlier this year.

Academic providers more often emphasized the benefits of biologics, and community providers were, on the whole, more supportive of using biologics as an adjunct to oral immunotherapy rather than as monotherapy. They were more likely to support the use of biologics for food allergies perceived as higher risk or patients who found it difficult to tolerate Palforzia.

Concerns about Costs

Providers identified several concerns about the use of biologics, including the insufficient evidence in food allergies, patient resistance and potential for overuse.

Edwin Kim, M.D.

“I share a lot of the same hopes as well as concerns for biologics,” coauthor Edwin Kim, M.D., chief of the Division of Pediatric Allergy and Immunology and director of the UNC Food Allergy Initiative at the UNC School of Medicine, said in a news release. “With omalizumab now approved and available for patients, it will be important to see if the expected benefits hold true in particular for those more difficult groups. In addition, seeing if the concerns for overuse and cost will come true and any safeguards that can be created to protect against this will also be important for the future of food allergy treatments.”

Providers also have concerns about the cost of biologics to treat food allergies. Xolair, for example, has a current list price of between $30,000 annually $60,000 annually. For the food allergy indication, Xolair is dosed by weight, from 75 mg to 600 mg by subcutaneous injection every two to four weeks. Palforzia has a cost of about $3,000 per year for the initial dose escalation and continued maintenance.

Research of Food Allergy Biologics

Several other biologic therapies for food allergy are being assessed in clinical trials. A drug with a similar mechanism is Dupixent, a biologic that targets IL-4 and IL-13 to reduce total IgE. Regeneron and Sanofi are conducting a phase 1 study of Dupixent in combination with the bispecific antibody linvoseltamab for severe food allergy. Linvoseltamab is an investigational therapy being studied separately for several cancer indications.

An investigational drug in development is Novartis’ ligelizumab, a monoclonal antibody that binds to immunoglobulin E. Novartis is also conducting an extension study to evaluate the long-term safety and efficacy of ligelizumab in participants who have completed a ligelizumab phase 3 study in food allergy. The company has, however, terminated a trial of ligelizumab specifically for peanut allergy.