FDA Approves Roche's Xolair (Omalizumab) for Nasal Polyps: First Anti-IgE Biologic to Reduce Polyp Size and Improve Symptoms

December 05, 2020 /BioValleyBIOON/ -- Roche recently announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for the anti-inflammatory drug Xolair (Chinese brand name: Zhuole; generic name: omalizumab), as an add-on maintenance therapy for adult patients (≥18 years) with nasal polyps who have an inadequate response to intranasal corticosteroids. Phase III clinical data demonstrated that treatment with Xolair reduced nasal polyp size (as defined by the Nasal Polyp Score [NPS]) and improved patients’ symptoms and quality of life.

Nasal polyps are a chronic condition that can lead to loss of smell and nasal congestion, and are often associated with other respiratory diseases (such as allergies andAsthma) occur simultaneously, severely impairing patients' quality of life. Symptoms include: chronic nasal congestion, difficulty breathing and sleeping, and loss of smell.

It is worth noting that Xolair is the first biologic agent specifically targeting and blocking immunoglobulin E (IgE) for the treatment of nasal polyps, with IgE being a key driver in the inflammatory pathway of this condition. The approval and market launch of Xolair will provide a new treatment option for patients in the United States with nasal polyps whose condition is not adequately controlled by intranasal corticosteroids, significantly improving their symptoms and quality of life.

Polyp 1 and Polyp 2Clinical TrialsJoseph Han, investigator and Director of the Division of Rhinology and Allergy at Eastern Virginia Medical School, stated: “In two pivotal Phase III studies, we observed significant reductions in nasal polyp volume and nasal congestion symptoms among patients with nasal polyps. These patients often have other respiratory and allergic symptoms that may further exacerbate their condition. With this approval, Xolair provides a new treatment option for these patients.”

Nasal Polyps (Image source: myhealthandwellnessinfo.com)

The approval of this new indication is based on the results of two Phase III clinical studies (POLYP 1 and POLYP 2). These two studies were randomized, multicenter, double-blind, placebo-controlled, replicate Phase III trials evaluating the efficacy and safety of Xolair in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who had an inadequate response to standard of care therapy (intranasal corticosteroids, INC). The POLYP 1 study enrolled 138 patients, and the POLYP 2 study enrolled 127 patients, including those with or without a history of surgery. In these studies, patients received subcutaneous injections of Xolair or placebo every 2–4 weeks, while receiving INC (mometasone nasal spray) as background therapy. The co-primary endpoints for both studies were the change from baseline in Nasal Polyp Score (NPS) and the change from baseline in average daily Nasal Congestion Score (NCS) over 24 weeks of treatment.

The results of these two studies were published in June 2020 in Allergy and ClinicalImmunologyJournal of Allergy and Clinical Immunology (JACI). The data showed that both studies met their co-primary endpoints: compared with the placebo group, patients in the Xolair treatment group achieved statistically significant improvements in mean Nasal Polyp Score (NPS) (POLYP 1: -1.08, p<0.0001; POLYP 2: -0.90, p=0.014) and daily Nasal Congestion Score (NCS) (POLYP 1: -0.89, p=0.0004; POLYP 2: -0.70, p=0.0017) at Week 24 of treatment. In both studies, patients in the Xolair treatment group demonstrated significant improvements in NPS and NCS as early as the first assessment (Week 4) compared with those in the placebo group.

Furthermore, two studies also met the key secondary endpoints: compared with the placebo group, patients in the Xolair treatment group demonstrated improvements in health-related quality of life as assessed by the Sino-Nasal Outcome Test-22 (SNOT-22), the University of Pennsylvania Smell Identification Test (UPSIT), the Total Nasal Symptom Score (TNSS), and olfaction; improvements were also observed in postnasal drip (posterior rhinorrhea) and runny nose (anterior rhinorrhea). In both studies, Xolair was well tolerated, and its safety profile was consistent with that observed in previous studies.

Nasal polyps are a common and potentially debilitating condition with limited treatment options currently available. After standard care, surgery and systemic steroids remain the mainstays of treatment. However, due to the recurrence of nasal polyps, these approaches often fail to effectively control long-term chronic symptoms.

Nasal polyps present as non-cancerous lesions on the inner walls of the sinuses or nasal cavity, accompanied by irritation and inflammation, which can obstruct normal airflow. Nasal polyps frequently co-occur with other respiratory conditions, affecting approximately 45% of adults with episodicAsthmaApproximately 30% of patients with chronic rhinosinusitis develop chronic rhinosinusitis with nasal polyps (CRSwNP) if symptoms of nasal polyps and sinusitis persist for 12 weeks or longer. Following sinus surgery, the recurrence rate of nasal polyps is as high as 80%, with approximately 40% of patients requiring at least one additional surgical intervention. Around 80% of patients remain uncontrolled 3–5 years after sinus surgery.

Notably, in June and October 2019, Sanofi and Regeneron’s anti-inflammatory drug Dupixent (dupilumab) was approved by the United States and the European Union for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose condition is inadequately controlled. In the United States and the European Union, Dupixent is the first biologic therapy approved for the treatment of CRSwNP.

Xolair is the only approved anti-IgE antibody medication that specifically targets, binds to, and blocks IgE. By reducing free IgE, downregulating high-affinity IgE receptors, and limiting mast cell degranulation, Xolair minimizes the release of mediators during the allergic inflammatory cascade. This prescription drug is administered via subcutaneous injection and has been approved in multiple countries worldwide for the treatment of moderate-to-severe persistent allergicAsthma(SAA), chronic spontaneous urticaria (CSU), and chronic idiopathic urticaria (CIU). In addition, the Xolair pre-filled syringe has been approved for marketing in many countries worldwide. In the U.S. market, the drug is co-developed and promoted by Genentech, a member of the Roche Group, in collaboration with Novartis; markets outside the United States are handled byNovartisResponsible for and record sales.

In China, Xolair (Chinese brand name: Zhuole; generic name: omalizumab) was approved in August 2017 for the treatment of patients aged 12 years and older with moderate-to-severe allergic asthma that is not adequately controlled with inhaled corticosteroids combined with long-acting β2-adrenergic agonists. This approval makes Xolair (Zhuole) the first therapy approved in China for the treatment ofAsthma's first targeted drug. (Bioon.com)

Original source:FDA approves Xolair? (omalizumab) for adults with nasal polyps