Omalizumab

Researchers at Boston Children’s Hospital are studying if Xolair can prevent asthma in young children with allergic conditions by blocking IgE, potentially halting the 'allergic march' toward asthma.

Sanofi and Regeneron plan to resubmit an FDA application for Dupixent in chronic spontaneous urticaria (CSU) by year-end, after a trial showed a 50% reduction in itch and urticaria activity scores. The companies also announced positive results in bullous pemphigoid and plan to seek U.S. approval for this indication. Despite challenges, Dupixent is used by 1 million patients across seven indications, with Japan being the first to approve it for CSU.

Tami McGraw, severely allergic to red meat, found relief through Xolair, originally for asthma, which also reduced her food allergies. After years of off-label use, Xolair was approved for food allergies in 2023, offering protection against accidental exposure and transforming lives, though it's not a cure. The drug's approval followed a pivotal clinical trial, OUtMATCH, which showed significant improvement in patients allergic to multiple foods. Xolair's potential to treat multiple allergies simultaneously and enhance oral immunotherapy effectiveness is under study.

News media often repeat drug makers' medical claims as news, giving pharma companies free advertising and potentially misleading consumers. Examples include a shingles vaccine's alleged dementia risk reduction, GLP-1 agonists' mental health benefits, and Xolair's new urticaria treatment, all linked to conflicts of interest. Medical journals complicate conflict of interest identification, and news media rarely investigate the sources of these claims.

Food allergies, affecting 8% of children and 6.2% of adults, can cause severe reactions requiring emergency care. Early allergen exposure may reduce future allergy risks. Advances include oral immunotherapies and FDA-approved drugs like Xolair, aiming to retrain the immune system. Genetics and environmental factors contribute to rising allergies, with research exploring prevention and treatment.

The European Commission approved SteQeyma®, an ustekinumab biosimilar, for treating chronic inflammatory diseases, based on Phase III study results showing its similarity to Stelara® in efficacy and safety for moderate to severe plaque psoriasis. This approval enhances Celltrion's immunology portfolio, offering patients affordable, high-quality biologic therapies.

The European Commission approved Celltrion's SteQeyma, a biosimilar to Stelara, for chronic inflammatory conditions. SteQeyma, effective against IL-12 and IL-23, offers subcutaneous and intravenous formulations. It matches Stelara in efficacy and safety, marking Celltrion's seventh EU-approved biosimilar, enhancing access to affordable biologics.

SteQeyma® (CT-P43), an ustekinumab biosimilar, received EC approval for treating chronic inflammatory diseases in gastroenterology, dermatology, and rheumatology. Based on Phase III study results, it's highly similar to Stelara® in efficacy and safety. Celltrion aims to expand its biosimilar portfolio, enhancing patient access to affordable biologic medicines.

A 4-year study on 191 patients with severe CRSwNP treated with biologics (Dupilumab, Mepolizumab, Omalizumab) showed significant symptom improvement, high patient satisfaction, and improved quality of life. Biologic therapy was well-tolerated, with sustained efficacy, reduced need for surgery and oral steroids, and positive impacts on comorbidities like asthma and allergic rhinitis.