FDA accepts application for Xolair prefilled syringe for self-administration across all indications. Novartis

Genentech, announced that the FDA accepted the company’s supplemental Biologics License Application (sBLA) for a new self-administration option for Xolair (omalizumab) across all approved U.S. indications. If approved, Xolair prefilled syringe would become available for either self-administration by select patients or administration by their caregivers. A decision on approval is anticipated by Q1 2021. In the U.S., Xolair is currently approved for administration by a healthcare provider in a healthcare setting, and is the only approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of patients with moderate to severe persistent allergic asthma and chronic idiopathic urticaria (CIU).