EU approves new indication for Novartis’ Xolair

The European Commission has approved a new indication for Novartis’ Xolair (omalizumab) as an add-on therapy for the treatment of adults with sever chronic rhinosinusitis with nasal polyps (CRSwNP).

The label extension is based on phase 3 studies that have shown that Xolair reduces nasal polyp size and improves symptoms, as well as qualify of life, in patients with CRSwNP.

According to Novartis, Xolair is the first treatment approved for CRSwNP which specifically targets and blocks immunoglobulin E (IgE), a key driver in the inflammatory pathway of the disease.

Xolair is already approved for the treatment of moderate-to-severe persistent allergic asthma in over 100 countries, including the US and EU. It is also approved for the treatment of chronic urticaria in the EU and chronic idiopathic urticaria in the US and Canada.

“People with chronic rhinosinusitis with nasal polyps can experience significant quality of life impairment as a result of their symptoms,” said Lars Ingemann, Academic Director of the European Forum for Research and Education in Allergy and Airway Diseases.

The symptoms include long-term nasal congestion and blockage, sleep disruption and loss of smell and taste,” he added.

CRSwNP affects up to 4% of people across the world, and is a potentially debilitating condition in adults that is characterised by inflammation of the nose and paranasal sinuses, with the presence of nasal polyps that can block normal airflow.