FDA Grants Approval to Groundbreaking Drug for Food Allergy Mitigation: Here's What You Need to Know

Coping with food allergies is challenging, requiring constant vigilance and the immediate availability of emergency epinephrine to counter life-threatening reactions from accidental ingestion.

However, a recent development saw the U.S. Food and Drug Administration (FDA) approving the first drug specifically designed to address potentially fatal food allergies. This approval signifies a significant breakthrough for the millions in the U.S. living with such allergies, offering hope in mitigating the associated risks.

Xolair: A Breakthrough in Allergy Treatment for Multiple Food Allergies

On Friday, February 16, the FDA granted approval to the antibody drug omalizumab, known as Xolair, as an injectable solution for reducing allergic reactions to foods in individuals aged 1 and older. In a trial involving 168 participants with multiple food allergies, those receiving omalizumab over 16 to 20 weeks were markedly more tolerant of allergy-inducing foods than those who received a placebo.

Having received prior approval for asthma, hives, and nasal polyps treatment, omalizumab operates by binding to immunoglobulin E (IgE) antibodies, crucial components in allergic responses. By preventing the binding of IgE to its target receptor, this monoclonal antibody drug effectively halts the immune responses that trigger allergy symptoms.

Xolair, falling under the category of monoclonal antibodies, precisely focuses on IgE, addressing an estimated 3.4 million children and 13.6 million adults diagnosed with IgE-mediated food allergies in the U.S. in 2024.

Advocates for individuals grappling with severe food allergies welcomed the FDA's approval, noting that it substantially expands treatment options to mitigate potentially fatal reactions.

While there is no cure for food allergies, patients traditionally rely on avoidance strategies. The FDA highlighted that Xolair, despite not eliminating food allergies or enabling unrestricted consumption of allergens, is the first approved medication to reduce allergic reactions to multiple types of food after accidental exposure, encompassing allergies to milk, egg, wheat, or nuts.

Dr. Kelly Stone from the FDA's Center for Drug Evaluation and Research emphasized that the drug's repeated use can help mitigate the health impact of accidental exposures.

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Omalizumab Trial Results

In the trial, participants with peanut allergies and at least two other food allergies, such as milk, egg, wheat, cashew, hazelnut, or walnut, were recruited. Those receiving omalizumab had shots every two to four weeks for 16 to 20 weeks.

In subsequent tests, 68 percent of those who received the drug could handle 600 milligrams or more of peanut protein without severe allergic symptoms, compared to only 6% in the placebo group. Similar positive outcomes were observed with other allergens like cashews, milk, and eggs.

However, the benefits were not universal, as 17% of those who received the drug showed no significant improvement in their sensitivity to allergy-triggering foods. The FDA emphasizes that even with Xolair, individuals should continue avoiding allergenic foods.

The ongoing trial, initiated in 2019 by the National Institute of Allergy and Infectious Diseases, provided early data convincing enough for the FDA to acknowledge the drug's significant benefits. It will continue to explore the drug's long-term effectiveness and its potential combination with oral immunotherapy (OIT).

The FDA notes common side effects such as injection site reactions and fever but also warns of potential joint pain, rash, parasitic infections, malignancies, and abnormal laboratory tests.

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