Xolair Receives New Indication to Treat Nasal Polyps

December 1, 2020 – The U.S. FDA has approved a new indication for Xolair® (omalizumab), manufactured by Genentech. The drug is now indicated for use as an add-on maintenance treatment for nasal polyps in adults who have had an inadequate response to nasal corticosteroids.

Nasal polyps are growths that develop in the nasal passages and affect an estimated 13 million people in the United States. These growths can lead to nasal congestion and discomfort, difficulty breathing through the nose, and problems with sense of smell. They may occur alongside other conditions that include allergies and asthma. Treatment options are currently limited, with many patients choosing systemic steroids or surgery to treat their polyps. However, polyps may return following these treatments.

In a clinical study, Xolair delivered statistically significant improvement in nasal polyp scores and weekly average nasal congestion scores compared to placebo at Week 24. Improvements in both scores were observed as early as Week 4 in some patients.

Recommended dosing under the new indication is 75 to 600mg administered as a subcutaneous injection every two to four weeks. The exact dose and dosing frequency should be determined based on the patient’s serum total immunoglobulin E level (a means of assessing allergic responses), as measured before starting treatment, and the patient’s weight.

A black box warning cautions that anaphylaxis, a potentially life-threatening allergic reaction, has been reported following the administration of Xolair. Xolair should only be administered in a healthcare setting by healthcare providers prepared to manage a life-threatening anaphylactic response. Patients should be closely observed for an appropriate period of time following administration.

First FDA approved in 2003, Xolair is also indicated to treat asthma and chronic idiopathic urticaria (a recurring form of hives).