1 December 2020 - - The US Food and Drug Administration has approved US-based biotechnology company Genentech's supplemental Biologics License Application 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, the company said.

Genentech is a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).

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, 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 and weekly average Nasal Congestion Score 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 (≥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.

Xolair is an injectable biologic medicine that is also FDA-approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

Approximately 460,000 patients have been treated in the US with Xolair since its initial approval for allergic asthma in 2003. In the US, Genentech and Novartis Pharmaceuticals Corp. work together to develop and co-promote Xolair.

Nasal polyps is a commonly occurring and potentially debilitating condition in adults, impacting 13 m people in the US Currently, there are limited treatment options available and many patients opt for nasal surgery or systemic steroids.

However, polyps may regrow over time. Nasal polyps present as noncancerous lesions on the lining of the nasal sinuses or nasal cavity associated with irritation and inflammation, which can block normal airflow. Nasal polyps may co-occur with other respiratory conditions, such as allergies and asthma.

POLYP 1 and POLYP 2 are replicate Phase III pivotal studies designed to determine the efficacy and safety of Xolair compared with placebo in adult patients with nasal polyps who had an inadequate response to nasal corticosteroids.

Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 involved 138 patients, and POLYP 2 involved 127 patients.

The co-primary outcomes for both trials were change from baseline to Week 24 in average daily Nasal Congestion Score and Nasal Polyp Score.

Patients in the studies were administered either Xolair or placebo by subcutaneous injection every two to four weeks in addition to background nasal mometasone therapy during both the treatment period and a five-week run-in period.

In the US, Xolair is the only approved antibody designed to target and block immunoglobulin E. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.