Omalizumab pre-filled syringes in EU

February 5, 2019 0 By FM

European Commission (EC) has approved omalizumab (Xolair) prefilled syringe for self-administration, allowing patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.

Omalizumab (Xolair) is the first biologic to offer the option of self-administration for SAA and CSU.

Omalizumab, which targets immunoglobulin E (IgE), is the first and only biologic to be approved in the EU, Iceland, Norway, and Liechtenstein for self-administration 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 antihistamines.

Studies in severe allergic asthma and chronic spontaneous urticaria have shown that appropriately trained patients can effectively self-administer omalizumab at home.

The efficacy of Xolair has been demonstrated in large-scale clinical trials and real-world studies. Xolair has been shown to reduce severe exacerbations and corticosteroid use in SAA, as well as rapidly reduce symptoms in CSU.