European approval for self-administration of Novartis’ Xolair

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Novartis has this week secured approval in Europe for Xolair prefilled syringe for self-administration.

The treatment allows patients with severe allergic asthma (SAA) and chronic spontaneous urticaria (CSU) to administer their own treatment.

Novartis said that with this approval, Xolair is the first and only biologic to offer the option of self-administration for SAA and CSU.

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.

The approval from the European Commission 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.

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.