The Food and Drug Administration (FDA) has accepted for filing the supplemental Biologics License Application (sBLA) for omalizumab (Genentech) for the treatment of adults with chronic rhinosinusitis with nasal polyps who have had an inadequate response to intranasal corticosteroids.
The sBLA includes data from the POLYP 1 and POLYP 2 trials, which showed that treatment with omalizumab, an anti-IgE antibody, resulted in statistically significant and clinically relevant improvements in both Nasal Congestion Score and Nasal Polyp Score, the co-primary end points. In addition, improvements in smell, posterior rhinorrhea, anterior rhinorrhea, and health-related quality of life (as measured by the Sino-Nasal Outcome Test-22) were also observed in the trials.
“Nasal polyps may limit patients’ ability to breathe and smell normally and causes other symptoms that can negatively impact their lives,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “Results from our two phase 3 studies in nasal polyps add to our understanding of [omalizumab] as a potential treatment option across allergic respiratory conditions and associated comorbidities.”
Omalizumab is currently marketed under the brand name Xolair for the treatment of moderate-to-severe persistent asthma in patients aged 6 years and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids. In addition, Xolair is indicated to treat chronic idiopathic urticaria in symptomatic patients 12 years of age and older despite H1-antihistamine treatment.
A decision on the approval of omalizumab for the treatment of nasal polyps is expected in the third quarter of 2020.
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