Research & Development
Genentech wins FDA approval of Xolair (omalizumab) for adults with nasal polyps
2 December 2020 -

Biotechnology company Genentech reported on Tuesday the receipt of the US Food and Drug Administration's (FDA) supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, including allergies and asthma.

Following the US FDA approval, Xolair is now the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation.

In the US, Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade, according to the company.

This FDA approval is based on results from the company's Phase III POLYP 1 and POLYP 2 trials, which showed that adult patients with nasal polyps who had an inadequate response to nasal corticosteroids and received Xolair had statistically greater improvement from baseline at Week 24 in Nasal Polyp Score (NPS) and weekly average Nasal Congestion Score (NCS) than patients who received placebo.

Xolair is now US FDA-approved across three diseases and in two formulations, continuing to build on the medicine's 17 years of patient experience since its initial approval for allergic asthma, concluded the company.



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