26 June 2020 - Decision based on results from the Phase III POLYP 1 and 2 studies, in which omalizumab significantly reduced the size of nasal polyps (defined by Nasal Polyp Score) and improved nasal congestion (defined by Nasal Congestion Score) compared with placebo.

Novartis today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Xolair (omalizumab) as an add-on therapy with intranasal corticosteroids (INC) 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. 

If approved, omalizumab will be the first treatment for nasal polyps specifically targeting and blocking immunoglobulin E (IgE), which helps to reduce the size of nasal polyps (as defined by Nasal Polyps Score; NPS) and improve symptoms. The European Commission reviews the CHMP recommendation and usually delivers its final decision within two months.

Read Novartis press release