Novartis Announces EU Approval of Xolair (Omalizumab) for Severe Chronic Rhinosinusitis with Nasal Polyps

August 07, 2020 News /BioValleyBIOON/ --Novartis(Novartis) recently announced that the European Commission (EC) has approved a new indication for the anti-inflammatory drug Xolair (Chinese brand name: Zhuole; generic name: omalizumab), as an add-on therapy to intranasal corticosteroids (INC) for the treatment of adult patients (≥18 years) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled with INC. Phase III studies demonstrated that Xolair reduced nasal polyp size (as defined by the Nasal Polyp Score [NPS]) and improved symptoms and quality of life in patients with CRSwNP.

This approval is based on the efficacy and safety profile of Xolair, which has accumulated over 1.3 million patient-years of exposure experience in severe allergicAsthmawith unparalleled real-world evidence in chronic spontaneous urticaria.

CRSwNP is a chronic disease that often co-occurs with other respiratory conditions, severely impairing patients' quality of life. Its symptoms include persistent nasal congestion, difficulty breathing and sleeping, and loss of smell.

It is worth mentioning that,Xolair is the first therapy specifically targeting and blocking immunoglobulin E (IgE) for the treatment of CRSwNP, IgE is a key driver of the inflammatory pathway in this disease. The approval and market launch of Xolair will provide a new treatment option that can significantly improve symptoms and quality of life for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) in Europe whose condition is not adequately controlled by intranasal corticosteroids (INC).

The approval of this new indication is based on the results of two Phase III clinical studies (POLYP 1 and POLYP 2). These were randomized, multicenter, double-blind, placebo-controlled, replicate Phase III studies 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 concurrently 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 the 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). 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 compared with those in the placebo group as early as the first assessment (Week 4).

Furthermore, two studies also met the key secondary endpoints: compared with the placebo group, patients in the Xolair treatment group showed 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 (Image source: myhealthandwellnessinfo.com)

Nasal polyps are a common and potentially debilitating condition with limited treatment options currently available. After standard care, surgery and systemic steroids remain the mainstay 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 episodicAsthmaIn patients, approximately 30% of those with chronic rhinosinusitis develop chronic rhinosinusitis with nasal polyps (CRSwNP) if symptoms of nasal polyps and sinusitis persist for 12 weeks or longer. Following endoscopic 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 within 3–5 years after sinus surgery.

Notably, in June and October 2019, Sanofi and Regeneron’s anti-inflammatory drug Dupixent (dupilumab) received approval in 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 both 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 numerous 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 multiple countries worldwide. In the US 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 whose condition is not adequately controlled with inhaled corticosteroids combined with long-acting β2-adrenergic agonists. This approval made Xolair (Zhuole) the first therapy approved in China for the treatment ofAsthma's first targeted drug. (Bioon.com)

Original source:Novartis receives EC approval for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps