The FDA has accepted a supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the treatment of nasal polyps in patients 18 years of age and older with inadequate response to intranasal corticosteroids, according to Genentech.
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 Q3 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 Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “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.”
Nasal polyps is a common and potentially debilitating condition in adults, impacting 13 million people in the US.
Currently, there are limited treatment options available and many patients opt for nasal surgery or systemic steroids, which often cannot effectively control symptoms over time due to nasal polyps regrowth.
Nasal polyps presents as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow.