Omalizumab Granted First FDA Indication for Children and Adults with Multiple Food Allergies

The biologic omalizumab was approved by the US Food and Drug Administration (FDA) on February 16, 2024, for the reduction of allergic reactions, including anaphylaxis, that can occur after accidental exposure to 1 or more foods, according to an announcement from Novartis.

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The new indication is for adults and children aged 1 year and older who have immunoglobulin-E (IgE)-mediated food allergy and renders omalizumab the first medication approved to reduce reactions in individuals who are allergic to multiple foods, Novartis states. There are approximately 160 foods that can trigger IgE-mediated allergic reactions.

Omalizumab is not for emergency treatment of any allergic reaction, including anaphylaxis, according to the company statement. Rather, the drug is administered subcutaneously once every 2 to 4 weeks in doses between 75 mg and 600 mg, with dose and frequency determined based on an individual’s weight and total serum IgE level. Anyone prescribed omalizumab to address food allergies should also continue to avoid foods that cause an allergic reaction, the company says.

"As more and more people are affected by food allergies, the need for a new approach to help prevent serious and often life-threatening allergic reactions and emergencies is critical," Sung Poblete, RN, PhD, chief executive officer of Food Allergy Research and Education said in the Novartis release. "As someone with food allergies, I know firsthand the significant impact they can have on people and their loved ones, and I share in the community's excitement for this approval." 

Findings from OUtMATCH

Foundational data for the FDA’s approval comes from the phase 3 OUtMATCH study, which enrolled individuals aged 1 to 55 years who were unable to tolerate up to 100 mg of peanut protein and up to 300 mg each of milk, egg, and 3 other nut proteins (cashew, hazelnut, and walnut). Eligibility required potential participants to be allergic to peanuts and at last 2 other allergens.

The primary outcome was the proportion of participants who could ingest a single dose of at least 600 mg (cumulative ≥1044 mg) of peanut protein without dose-limiting symptoms and the secondary outcome, the proportion who could consume at least 1000 mg of milk, egg, or cashew protein, without a moderate to severe allergic reaction.

After 16 to 20 weeks of treatment with omalizumab or placebo, participants were assessed using 4 food challenges comprised of gradually increasing amounts of their specific allergens with the goal of tolerating the single dose of peanut or other protein.

The investigators reported a significantly greater proportion of omalizumab-treated participants (66.7%) vs placebo treated participants (6.7%) were able to tolerate at least 600 mg of peanut protein (OR, 28.0; 95% CI 9.2-112; P < .001).

Similarly, significantly more participants who received omalizumab than received placebo injections tolerated at least 1000 mg of protein from milk (66% vs 11%; P < .001), egg (67% vs 0%; P < .001) or cashew (42% vs. 3%; P < .001) without moderate to severe allergic symptoms.

600 mg is equivalent to approximately two and a half peanuts or half a teaspoon of regular peanut butter.

1000 mg is equivalent to approximately two tablespoons of 1% milk, one-quarter of an egg or three and a half cashews.

The most common adverse events, occurring in 3% or more of participants, were injection site reactions and fever, Novartis said. The study’s safety findings were consistent with the omalizumab safety profile observed in previous clinical trials, across the drug’s additional indications, including for other allergic and inflammatory conditions such as chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps. .

"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, president and chief executive officer of the Asthma and Allergy Foundation of America said. "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."

Additional details from the OUtMATCH trial will be announced during a session featuring late-breaking science at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting on Sunday, February 25, 2024.

Source: FDA approves Xolair (omalizumab) as first and only medicine for children and adults with one or more food allergies. News release. Novartis. February 16, 2024. Accessed February 19, 2024. https://www.novartis.com/us-en/news/media-releases/fda-approves-xolair-omalizumab-first-and-only-medicine-children-and-adults-one-or-more-food-allergies