Logo

Roche Reports the US FDA's Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Share this

Roche Reports the US FDA's Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots:

  • The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21
  • The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA)
  • If approved- Xolair's prefilled syringe will become available for either self-administration by select patients or administration by their caregivers.  Genentech and Novartis work together to develop and co-promote Xolair in the US

­ Ref: Roche | Image: Roche 

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions