Posted by Michael Wonder on 13 Aug 2020
Novartis announces FDA filing acceptance of Xolair (omalizumab) pre-filled syringe for self-administration across all indications
13 August 2020 - If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment needs.
Novartis today announced that the US FDA accepted the company's supplemental biologics license application for a new self-administration option for Xolair (omalizumab) across all approved US indications.
If approved, Xolair pre-filled 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 US, Xolair is currently approved for administration by a health care 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.
