Posted by Michael Wonder on 11 Dec 2019
FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
10 December 2019 - The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies of Xolair in adults with chronic rhinosinusitis with nasal polyps with inadequate response to intranasal corticosteroids.
Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application 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. The FDA is expected to make a decision on approval for this indication by Q3 2020.
