Novartis receives European Commission approval for self-administration of Xolair across all indications

Novartis International AG / Novartis receives European Commission approval for self-administration of Xolair across all indications . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• 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[1]
   

Xolair (omalizumab) prefilled syringe (PFS) is the first and only biologic to receive European Commission (EC) approval for self-administration in severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU)
 

Novartis is reimagining care in SAA and CSU by providing patients the flexibility to fit their treatment around their lives

Basel, December 13, 2018 - Novartis today announced that the European Commission (EC) has approved Xolair (omalizumab) prefilled syringe (PFS) 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 (IgE), 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 antihistamines. Studies in severe allergic asthma and chronic spontaneous urticaria have shown that appropriately trained patients can effectively self-administer Xolair at home[1]-[3].

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[1], as well as rapidly reduce symptoms in CSU[4].

The EC approval will allow patients with no known history of anaphylaxis to self-inject Xolair PFS, or be injected by a trained lay-caregiver, from the fourth dose onwards, if a physician determines that this is appropriate[5]. The patient or the caregiver must have been trained in the correct sub-cutaneous injection technique and the recognition of the early signs and symptoms of serious allergic reactions[5].