Shots:

• The sBLA submission is based on P-III POLYP 1 & 2 studies assessing Xolair (SC) vs PBO in 138 & 127 patients with CRSwNP with inadequate response to intranasal corticosteroids respectively
• The P-III POLYP 1 & 2 studies resulted in meeting its 1EPs and 2EPs i.e- change in NPS & NCS score @24wks. and improvement in SNOT-22- health-related QoL assessment- improvement in sense of smell- post-nasal drip & runny nose respectively
• Xolair is a biologic targeting IgE and if approved- will be the first Ab that helps in reducing the size of nasal polyps and in improving symptoms with its anticipated FDA’s approval in Q3’20

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 Ref: Roche | Image: Roche