FDA Approves Omalizumab For Treatment of Nasal Polyps

The FDA has approved omalizumab (Xolair, Genentech) for the treatment of nasal polyps in adults.

Nasal polyps, which frequently co-occur with other respiratory conditions such as allergies and asthma, can lead to a loss of smell and nasal congestion. Nasal polyps affect approximately 13 million people across the United States. With limited treatment options, many opt for surgery or steroids. Omalizumab’s approval marks the first biologic treatment for nasal polyps that target and black immunoglobulin E (IgE).

The approval is based on the phase 3 POLYP 1 and POLYP 2 trials, which enrolled 138 patients in POLYP 1 and 127 patients in POLYP 2. Patients were either given omalizumab or a placebo after an inadequate response to nasal corticosteroids.

The placebo or omalizumab were given by subcutaneous injection ever 2 to 4 weeks in addition to background nasal mometasone therapy, according to the study. In both trials, the co-primary outcomes were changed from baseline to week 24 in average daily Nasal Congestion Score (NCS) and Nasal Polyp Score (NPS)

Improvements in NPS and NCS over the placebo group were seen as early as 4 weeks in both studies. At week 24, those treated with omalizumab saw a mean change in NPS of -1.1 compared with the baseline. Those who received the placebo had a 0.1 change from the baseline. In NCS, those treated with omalizumab experienced a -0.9 and -0.7 change from the baseline whereas those treated with the placebo showed a -0.4 and -0.2 change.

“Adults living with nasal polyps may not be able to breathe through their nose and smell normally, and currently have limited treatment options,” said Tonya Winders, president and CEO of the Allergy & Asthma Network, in a press release. “The approval of Xolair is welcome news for the community, providing another option to treat patients and help alleviate their symptoms.”

More than 95% of the patients completed the safety arm of POLYP 1 and POLYP 2. Common adverse effects included headache, injection site pain, site reaction, and arthralgia.

REFERENCE:

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