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.
France Dernières Nouvelles, France Actualités
Similar News:Vous pouvez également lire des articles d'actualité similaires à celui-ci que nous avons collectés auprès d'autres sources d'information.
FDA Approves First Treatment for Severe FrostbiteThe U.S. Food and Drug Administration (FDA) on Wednesday approved the first treatment for severe frostbite.
Lire la suite »
FDA Approves First Cellular Therapy for Metastatic MelanomaLifileucel is the first cellular therapy to be approved to treat patients with unresectable or metastatic melanoma.
Lire la suite »
FDA approves groundbreaking treatment for advanced melanomaErika Edwards is a health and medical news writer and reporter for NBC News and 'TODAY.'
Lire la suite »
FDA Denies Application for New Antifungal DrugThe Food and Drug Administration has denied an application for a new antifungal drug called olorofim, requesting more data. Fungal infections pose a growing threat to human health, and doctors are in need of new medicines to combat this problem.
Lire la suite »
Recalled applesauce pouches likely contained lead due to a single cinnamon processor the FDA just identifiedEcuador's authorities allege that Carlos Aguilera, a cinnamon grinder in Ecuador, is 'the likely source' of the contaminated spices that led to the recall of WanaBana applesauce.
Lire la suite »
Screening and Treatment Reduce Breast Cancer MortalitySimulation models indicate that breast cancer screening and treatment were associated with a 58% reduction in mortality, based on data collected between 1975 and 2019.
Lire la suite »