FDA OKs Omalizumab for Maintenance Treatment of Nasal Polyps

Officials with the FDA have approved the supplemental Biologics License Application (sBLA) for omalizumab (Xolair; Genentech and Novartis) for the add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids, according to a press release.

With this approval, omalizumab is the first biologic treatment for nasal polyps that targets and blocks immunoglobulin E (IgE), which is a key driver of inflammation. Omalizumab is also FDA approved for the treatment of moderate-to-severe persistent allergic asthma in individuals 6 years of age and older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria in individuals 12 years of age and older.

The FDA approved this sBLA based on results from the phase 3 POLYP 1 and POLYP 2 studies, which evaluated omalizumab versus placebo in patients with nasal polyps who did not respond to nasal corticosteroids.

According to the results, treatment with omalizumab demonstrated statistically significant greater improvement in patients with nasal polyps compared with placebo. These improvements were measured from baseline at week 24 in Nasal Polyp Score (NPS) and weekly average Nasal Congestion Score (NCS).

At week 24, the mean change from baseline for omalizumab compared with placebo in both studies were: NPS, -1.1 versus 0.1 (95% CI: -1.6, -0.7) and -0.9 versus -0.3 (95% CI: -1.1, -0.1); NCS, -0.9 versus -0.4 (95% CI: -0.8, -0.3) and -0.7 versus -0.2 (95% CI: -0.8; -0.2). The full results from these trials were recently published in the Journal of Allergy and Clinical Immunology.

Additionally, no new or unexpected safety signals were observed with omalizumab, with over 95% of patients completing each safety arm of the trials. The most common adverse reactions included headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.

“With Xolair, we observed significantly reduced nasal polyps and congestion in symptoms in adults who had nasal polyps in 2 pivotal phase 3 studies,” study investigator Joseph Han, MD, chief of the division of rhinology and the division of allergy at Eastern Virginia Medical School, said in a statement. “Xolair provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms.”

Reference

1. Genentech Announces FDA Approval of Xolair (omalizumab) for Adults with Nasal Polyps. News release. Genentech; December 1, 2020. Accessed December 1, 2020. https://www.gene.com/media/press-releases/14887/2020-12-01/genentech-announces-fda-approval-of-xola