Home Medizin FDA genehmigt Medikament zur Reduzierung unbeabsichtigter Nahrungsmittelallergien

FDA genehmigt Medikament zur Reduzierung unbeabsichtigter Nahrungsmittelallergien

von NFI Redaktion

The US Food and Drug Administration (FDA) has approved Omalizumab (Xolair, Genentech) for reducing allergic reactions to food in adults and most children. The medication is intended to be taken regularly by patients with food allergies to reduce the risk of reactions, including anaphylaxis, in the event of accidental exposure to one or more allergens. The injection is not approved for the emergency treatment of allergic reactions.

Omalizumab was initially approved in 2003 for the treatment of persistent allergic asthma. It is also approved for the treatment of chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps.

The new indication for IgE-mediated food allergies in adults and children over one year of age makes Omalizumab the first approved medication for relieving allergic reactions to more than one food, according to the FDA. Peanut allergen powder (Palforzia) can reduce reactions to peanuts, but its benefit is limited to this allergy.

The safety and effectiveness of the monoclonal antibody in reducing allergic reactions were studied in a double-blind, placebo-controlled trial involving 168 children and adults allergic to peanuts and at least two other foods, including milk, egg, wheat, cashew, hazelnut, or walnut. Patients received Omalizumab or placebo for 16-20 weeks. At the end of the study, patients were exposed to peanut protein (equivalent to 2.5 peanuts). 68% of those who received the medication were able to consume peanuts without experiencing moderate or severe allergic symptoms, compared to 6% in the placebo group.

More patients who received the medication also avoided moderate or severe reactions to cashews (42% vs 3%), milk (66% vs 11%), and eggs (67% vs 0%).

The most common side effects of Omalizumab included injection site reactions and fever. The drug label includes warnings and precautions for anaphylaxis, cancer, fever, joint pain, rash, parasitic (worm) infections, and abnormal lab tests. Omalizumab comes with a warning for anaphylaxis and should only be administered in a healthcare facility equipped to treat anaphylaxis, according to the FDA.

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