The Food and Drug Administration (FDA) has expanded the approval of Xolair® (omalizumab; Genentech and Novartis), an immunoglobulin E (IgE) blocker, to include add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.
The approval was supported by data from the phase 3 POLYP 1 (N=138) and POLYP 2 (N=127) trials evaluating the efficacy and safety of Xolair in adults with nasal polyps who had an inadequate response to nasal corticosteroids. Patients were randomized to receive either Xolair or placebo by subcutaneous injection every 2 to 4 weeks. The co-primary end points for both trials were change from baseline in Nasal Polyp Score (NPS) at week 24, and change from baseline in average daily Nasal Congestion Score (NCS) to week 24.
Results from both trials showed that patients treated with Xolair had a statistically significant greater improvement from baseline at week 24 in NPS and NCS compared with placebo, with improvements observed as early as week 4. Moreover, Xolair demonstrated statistically significant improvements on sense of smell score, post-nasal drip, and runny nose in both trials. The most common adverse reactions reported included headache, injection site reaction, arthralgia, upper abdominal pain and dizziness.
“With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in 2 pivotal phase 3 studies,” said Joseph Han, MD, Chief of the Division of Rhinology and the Division of Allergy at Eastern Virginia Medical School and study investigator of the POLYP 1 and POLYP 2 trials. “Xolair provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms.”
Xolair is available as a prefilled syringe (75mg/0.5mL and 150mg/mL) and as a single-dose vial containing lyophilized powder for reconstitution (150mg); both formulations need to be administered by a health care professional. The recommended dosage for nasal polyps should be based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg). For patients with both asthma and nasal polyps, the dosing should be determined by the primary diagnosis for which the drug is being prescribed.
Genentech announces FDA approval of Xolair (omalizumab) for adults with nasal polyps. [press release]. South San Francisco, CA: Genentech, Inc; December 1, 2020.
Novartis announces FDA approval of Xolair® (omalizumab) for adults with nasal polyps. [press release]. East Hanover, NJ: Novartis; December 1, 2020.
Xolair® [package insert]. South San Francisco, CA: Genentech, Inc; 2020.