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

Novartis 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.

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 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. 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.

“Today’s positive news is a big step forward for patients living with immunoglobulin E- mediated asthma and chronic spontaneous urticaria. Decreasing the number of regular clinic visits allows patients the flexibility to fit their treatment around their lives and helps to reduce the burden of these diseases. It also allows physicians a greater capacity for patients who need extra care, which is important” said Professor Dr. Karl-Christian Bergmann, Allergy Center Charité, Berlin.

Administered via injection every two or four weeks, Xolair is widely used and well tolerated[6]. With 13 years of physician experience in Europe and one million patient years of exposure, use of Xolair in SAA and CSU is supported by a wealth of evidence from randomized clinical trials and real-world studies. Anaphylactic reactions were rare in clinical trials (>= 1/10,000 to < 1/1,000)[5] and via post-marketing reports (approximately 0.2 percent).