Novartis announces FDA filing acceptance of Xolair Omalizumab

The US Food and Drug Administration (FDA) has accepted the Novartis’ supplemental Biologics License Application (sBLA) for Xolair (Omalizumab) for the treatment of nasal polyps in adult patients, 18 years of age and older, with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E (IgE). The FDA is expected to make a decision on approval for this indication by 3Q2020.

Xolair is an injectable biologic medicine designed to target and block IgE. Xolair is currently approved for the treatment of moderate to severe persistent allergic asthma in people, six years of age or older, whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people, 12 years of age and older, who continue to have hives that are not controlled by H1 antihistamines. In the US, Novartis Pharmaceuticals Corporation and Genentech work together to develop and co-promote Xolair.