Posted by Michael Wonder on 13 Dec 2018
Novartis receives European Commission approval for self-administration of Xolair across all indications
13 December 2018 - The EC approval underscores the long-term safety and efficacy of Xolair demonstrated in clinical studies and by 13 years of real-world use in Europe.
Novartis today announced that the European Commission has approved Xolair (omalizumab) pre-filled syringe for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment. With this approval, Xolair is the first and only biologic to offer the option of self-administration for SAA and CSU.
Xolair, which targets immunoglobulin E, is the first and only biologic to be approved in the European Union, Iceland, Norway, and Liechtenstein for self-administration (or administration by a trained caregiver) for the treatment of SAA in patients 6 years of age and older that have difficulty in controlling their asthma symptoms and for CSU in patients 12 years of age and older who continue to have hives that are not controlled by H1 anti-histamines. Studies in severe allergic asthma and chronic spontaneous urticaria have shown that appropriately trained patients can effectively self-administer Xolair at home.
