Respiratory - September 2020

Respiratory - September 2020

FDA Accepts Application for Xolair (omalizumab) prefilled syringe for self-administration across all indications

12 Aug 2020

Xolair (Omalizumab, Anti-IgE mAb) – Genentech/Novartis

  • The application acceptance is based on the well-established efficacy and safety profile of Xolair in allergic Asthma and Chronic idiopathic urticaria
  • Xolair is currently approved in the US for administration by a healthcare provider in a healthcare setting for the treatment of patients with moderate to severe persistent allergic Asthma and Chronic idiopathic urticaria (CIU)
  • It is the only approved biologic designed to target and block (IgE) to treat allergic Asthma and CIU
  • Approval is anticipated by Q1’21
  • If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers with proper training

FDA accepted Genentech's application for Xolair prefilled syringe for self-administration across all indications

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CI Scientists Remarks: 

  • FDA acceptance of Genentech/Novartis’ sBLA for Xolair new self-administration option may offer a more flexible option to help select patients manage their treatment needs
  • In the US, Genentech and Novartis develop and co-promote Xolair. In 2018, Xolair was approved for both allergic Asthma and Chronic idiopathic urticaria indications as a prefilled syringe (PFS) formulation

– Dr. Kowndinya, CI Scientists

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