European Commission approves Novartis’ Xolair® (omalizumab)

The European Commission (EC) has approved Xolair® (omalizumab) as an add-on therapy with intranasal corticosteroids (INC). The drug is for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with INC does not provide adequate disease control. The approval was given to Novartis. 

Phase III studies showed that Xolair reduced nasal polyp size and improved symptoms and quality of life in patients with CRSwNP.

According to Novartis, Xolair is the first treatment for CRSwNP specifically targeting and blocking immunoglobulin E (IgE), a key driver in the inflammatory pathway of this disease. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimises the release of mediators throughout the allergic inflammatory cascade.

“People with chronic rhinosinusitis with nasal polyps can experience significant quality of life impairment as a result of their symptoms. The symptoms include long-term nasal congestion and blockage, sleep disruption and loss of smell and taste,” said Lars Ingemann, Academic Director of the European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA). “The EUFOREA patient advisory board welcomes today’s approval, which will provide an additional treatment option to patients with severe chronic rhinosinusitis with nasal polyps.”

Currently, after standard-of-care intranasal corticosteroids (INC), surgery and systemic corticosteroids are the main treatments for this disease all over the world. However, they are often not effective in controlling chronic symptoms over time, due to nasal polyp regrowth.

An injectable prescription medicine, Xolair has already been approved for the treatment of moderate-to–severe or severe persistent allergic asthma in more than 100 countries.