The US Food and Drug Administration (FDA) has agreed to review a supplemental biologics license application (sBLA) submitted by Novartis to seek approval for Xolair (omalizumab) to treat nasal polyps.
Xolair is a biologic injection that blocks immunoglobulin E (IgE). The drug already has the approval to treat moderate-to-severe persistent allergic asthma in some patients aged six years above and chronic idiopathic urticaria (CIU) in select patients aged 12 years and older.
If approved, the drug is expected to be the first-of-its-kind to decrease the size of nasal polyps, as well as improve symptoms. The US regulator is anticipated to provide a decision by the third quarter of next year.
Novartis Pharmaceuticals president Victor Bultó said: “With millions of Americans living with this serious respiratory condition, there is a significant unmet need for additional treatment options for patients who do not respond to intranasal corticosteroids.
“The FDA’s acceptance of this sBLA is an important step on our path to continually reimagining medicine and understanding the full potential of Xolair across allergic, respiratory and inflammatory conditions and associated comorbidities.”
The sBLA includes data gathered from the Phase III POLYP 1 and POLYP 2 clinical trials performed in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who had an inadequate response to intranasal corticosteroids.
Both trials met the co-primary and principal secondary endpoints with Novartis ’ drug.
The co-primary endpoints were the change in Nasal Polyp Score (NPS) and average daily Nasal Congestion Score (NCS) from baseline to 24 weeks.
Principal secondary endpoints included improvements in the quality of life, determined using the Sino-Nasal Outcome Test-22 (SNOT-22) health assessment, sense of smell, post-nasal drip and runny nose.
Novartis submitted an application to the European Medicines Agency (EMA) in November for approval of Xolair to treat nasal polyps and are anticipating a decision by next year.