FDA accepts sBLA for Xolair for nasal polyps

The US Food and Drug Administration has accepted the 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, Swiss pharma giant Roche (ROG: SIX) announced today.

If approved, Xolair – which is co-developed and co-promoted in the USA by Roche subsidiary Genentech and Swiss peer Novartis (NOVN: VX) - 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 third-quarter 2020.

“Nasal polyps may limit patients’ ability to breathe and smell normally and causes other symptoms that can negatively impact their lives. There is a critical need for new treatment options for the millions of people living with this condition,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development, adding: “Results from our two Phase III studies in nasal polyps add to our understanding of Xolair as a potential treatment option across allergic respiratory conditions and associated comorbidities.”