South San Francisco, CA — December 1, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (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.
“With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in two pivotal Phase III studies,” said Joseph Han, M.D., 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.”
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.
“With today’s approval, people living with nasal polyps now have a treatment option that targets IgE, an underlying driver of various allergic conditions,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are committed to understanding the full potential of Xolair across the spectrum of allergic diseases and are excited to provide this important treatment for people living with nasal polyps.”
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.
“Adults living with nasal polyps may not be able to breathe through their nose and smell normally, and currently have limited treatment options,” said Tonya Winders, President and CEO, Allergy & Asthma Network. “The approval of Xolair is welcome news for the community, providing another option to treat patients and help alleviate their symptoms.”
Xolair is an injectable biologic medicine that is also FDA-approved for the treatment of moderate to severe persistent allergic asthma in people 6 years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) 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 U.S. with Xolair since its initial approval for allergic asthma in 2003. In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.
About Nasal Polyps
Nasal polyps is a commonly occurring and potentially debilitating condition in adults, impacting 13 million people in the U.S. 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.
About POLYP 1 and POLYP 2
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 U.S., Xolair is the only approved antibody designed to target and block immunoglobulin E (IgE). 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.
Xolair U.S. Indications
Xolair (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:
- moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not controlled with their current asthma medicines. A skin or blood test is performed to see if people have allergies to year-round allergens.
- nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough. It is not known if Xolair is safe and effective in people with nasal polyps under 18 years of age.
- chronic idiopathic urticaria (CIU, chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with their current CIU medicines.
Xolair is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Posted: December 2020
Xolair (omalizumab) FDA Approval History