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

August 13, 2020 Auto Bot Acceptance, All, Biotech, FDA, regulatory, reports, Roche, sBLA 0

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

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