Roche and Novartis Report the US FDA’s Acceptance of sBLA for Xolair (omalizumab) to Treat Nasal Polyps

 Roche and Novartis Report the US FDA’s Acceptance of sBLA for Xolair (omalizumab) to Treat Nasal Polyps

Roche and Novartis Report the US FDA’s Acceptance of sBLA for Xolair (omalizumab) to Treat Nasal Polyps

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

Click here to­ read full press release/ article | Ref: Roche | Image: Exhibitor Online

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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