Genentech announces FDA approval of supplemental BLA of Xolair for add-on maintenance treatment of nasal polyps.

Genentech, a member of the Roche Group announced that the FDA has approved the company’s supplemental Biologics License Application (sBLA) for Xolair (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation. The FDA’s approval is based on results from the Phase III POLYP 1 and POLYP 2 trials. Both trials showed that adult patients with nasal polyps who had an inadequate response to nasal corticosteroids and received Xolair had statistically significant greater improvement from baseline at Week 24 in Nasal Polyp Score (NPS) and weekly average Nasal Congestion Score (NCS) than patients who received placebo. The greater improvements in NPS and NCS in the Xolair group compared to the placebo group were observed as early as the first assessment at Week 4 in both studies. All patients received background nasal mometasone therapy during both the treatment period and a five-week run-in period. In POLYP 1 and POLYP 2, the mean change from baseline at Week 24 for Xolair compared to placebo 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). POLYP 1 and POLYP 2 are the ninth and tenth Phase III trials for Xolair, respectively. Results from POLYP 1 and POLYP 2 were recently published in the Journal of Allergy and Clinical Immunology. No new or unexpected safety signals were identified in patients treated with Xolair, with over 95% of patients completing each safety arm of POLYP 1 and POLYP 2. The most common adverse reactions ( greater than 3% of patients) included headache, injection site reaction, arthralgia, upper abdominal pain and dizziness. The safety profile in POLYP 1 and POLYP 2 was consistent with the established safety profile for Xolair.