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Roche Reports the US FDA’s Approval of Xolair for Treating Food Allergies

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Roche Reports the US FDA’s Approval of Xolair for Treating Food Allergies

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  • 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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Click here to­ read the full press release 

Shivani Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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