The US FDA grants approval to Roche’s Xolair (omalizumab) for reducing allergic reactions like anaphylaxis caused by accidental exposure to one or more foods in IgE-mediated food allergic adult and pediatric patients (1yr. & above)
The approval was supported by results of the P-III (OUtMATCH) trial assessing Xolair vs PBO for reducing allergy in patients (1yr. to 55yrs.) due to peanuts and at least two other food allergens
The results demonstrated that treatment with Xolair after 16-20wks. showed tolerance of 600mg peanut protein (68% vs 5%), 1,000mg protein from milk (66% vs 11%), egg (67% vs 0%) or cashew (42% vs 3%) without moderate to severe allergic symptoms was seen in high no. of patients
Ref: Roche | Image: Roche
Related News:- Alvotech Entered into an Exclusive License Agreement with Kashiv BioSciences to Develop and Commercialize AVT23, a Proposed Biosimilar to Xolair (omalizumab)
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