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
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