- Source : Press Release
- Date : 2021-04-19
- Event type : Approved
- Companies : Roche
Novartis' Xolair Wins Nod for Treating Adults With Nasal Polyps
Novartis said Monday that Xolair (ingredient: omalizumab) received the approval of the Ministry of Food and Drug Safety to treat chronic rhinosinusitis with nasal polyps not properly regulated by nasal corticosteroids in people over 18.
The expanded indication is based on global phase 3 POLYP1 and POLYP2 clinical studies that evaluated the efficacy and safety of Xolair in adult nasal polyp patients who showed inappropriate responses to daily nasal corticosteroid therapy.
In the two studies, Xolair showed statistically significant improvement in Nasal Polyp Score and Nasal Congestion Score after administering for 24 weeks in nasal polyp patients compared to the placebo group.
Researchers observed a significant improvement in NPS and NCS in Xolair-treated patients compared to the placebo group in the first assessment at the fourth week in both clinical trials.
The Sino-Nasal Outcome Test-22, a specific questionnaire for rhinosinusitis, and the University of Pennsylvania Smell Identification Test, which evaluates olfactory perception, and the Total Nasal Symptom Score, which assesses the degree of improvement in nasal symptoms, also showed significant improvement in the Xolair-treated group compared to the placebo group.
Nasal polyps are benign mucosal swelling formed in the shape of a grape cluster on the lining of the nasal cavity or sinuses, which could cause nasal congestion and loss of smell. Patients with respiratory diseases, including severe allergies and asthma, develop nasal polyps.
Patients relied on surgery or systemic steroids but needed new therapeutic options as the disease showed high recurrence. The Health Insurance Review and Assessment Service data showed an average of 20,000 Koreans have been receiving treatments for nasal polyps.
“We are pleased to offer new treatment options to patients with nasal polyps in Korea with the recently expanded indication of Xolair,” said Joseph Liu, senior director of Novartis' ophthalmology and respiratory business unit. “We hope the quality of life of patients with nasal polyps who have suffered from prolonged nasal congestion and loss of smell to improve with Xolair.”
Xolair is the first biological drug approved for treating nasal polyps that target and block Immunoglobulin E, which is the cause of inflammation.