The new indication makes Xolair (omalizumab) the first drug approved to mitigate allergic reactions to more than one food.
for reducing allergic reactions to foods in adults and most children. The drug is meant to be taken regularly by patients with, in case of accidental exposure to one or more allergens. The injection is not approved for emergency treatment of an allergic reaction.The new indication for immunoglobulin E–mediated food allergy in adults and children aged 1 year or older makes omalizumab the first drug approved to mitigate allergic reactions to more than one food, the FDA said.
"While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs," said Kelly Stone, MD, PhD, associate director of the division of pulmonology, allergy, and critical care in the FDA's Center for Drug Evaluation and Research, in a news release.
More patients who received the medication also avoided moderate or severe reactions to cashews , milk , and eggs . The most common side effects of omalizumab included injection site reactions and fever. The drug's label includes warnings and precautions about anaphylaxis, cancer, fever, joint pain, rash, parasitic infection, and abnormal laboratory tests. Omalizumab comes with a boxed warning for anaphylaxis and should be started only in a healthcare setting equipped to manage anaphylaxis, according to the FDA.
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