Novartis : receives EC approval for new Xolair indication to treat severe chronic rhinosinusitis with nasal polyps – Marketscreener.com

§ August 12th, 2020 § Filed under Nano Medicine Comments Off on Novartis : receives EC approval for new Xolair indication to treat severe chronic rhinosinusitis with nasal polyps – Marketscreener.com

Basel, August 6, 2020 - Novartis today announced that the European Commission (EC) has approved Xolair (omalizumab) as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe chronic rhinosinusitis with nasal polyps (CRSwNP) for whom therapy with INC does not provide adequate disease control1. Phase III studies have shown that Xolair reduces nasal polyp size (defined by Nasal Polyp Score; NPS) and improves symptoms and quality of life in patients with CRSwNP5. Xolair is the first treatment for CRSwNP specifically targeting and blocking immunoglobulin E (IgE), a key driver in the inflammatory pathway of this disease.

'People with chronic rhinosinusitis with nasal polyps can experience significant quality of life impairment as a result of their symptoms. The symptoms include long-term nasal congestion and blockage, sleep disruption and loss of smell and taste,' said Lars Ingemann, Academic Director, EUFOREA*. 'The EUFOREA* patient advisory board welcomes today's approval, which will provide an additional treatment option to patients with severe chronic rhinosinusitis with nasal polyps.'

*EUFOREA: The European Forum for Research and Education in Allergy and Airway Diseases

About Xolair (omalizumab) Xolair is the only approved anti-immunoglobulin E (IgE) antibody treatment specifically designed to target and block 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.

An injectable prescription medicine, Xolair is approved for the treatment of moderate-to-severe or severe persistent allergic asthma in more than 100 countries, including the US since 2003 and the EU since 2005. Xolair is approved for the treatment of chronic spontaneous urticaria in over 90 countries including the EU and for chronic idiopathic urticaria (CIU), as it is known in the US and Canada. Xolair has over 1.3 million patient years of exposure. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in the EU and in more than 20 countries outside of the EU, including Canada, the US and Australia. The self-administration indication for Xolair in pre-filled syringes was also approved in the EU in 2018, and has since been approved in several other countries, including Australia, Taiwan, Argentina and Brazil. In the US, Novartis and Genentech, Inc. work together to develop and co-promote Xolair. Outside of the US, Novartis markets Xolair and records all sales and related costs.

For chronic rhinosinusitis with nasal polyps (CRSwNP), Xolair is indicated in the EU as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control1.

About Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Chronic rhinosinusitis with nasal polyps (CRSwNP) impacts up to 4% of people worldwide. It is a potentially debilitating condition in adults that is characterized by inflammation of the nose and paranasal sinuses with the presence of benign inflammatory polyps (nasal polyps) on the lining of the nasal sinuses or nasal cavity, which can block normal airflow2-4. It is possible to have a single polyp or several, and the size of the polyps can vary from microscopic to several centimeters6,7.

Symptoms can include nasal blockage/obstruction, nasal congestion, nasal discharge, facial pain/pressure and reduction in, or loss of, sense of smell2,3. CRSwNP is diagnosed by a physical examination with endoscopy. The condition can be associated with asthma, cystic fibrosis and aspirin sensitivity8. It is also associated with significant morbidity and decreased health-related quality of life, with quality of life impairment9-14. Patients with CRSwNP experience significantly lower health-related quality of life than the general population, with a greater impact for patients with more severe disease, other conditions (comorbidities) or whose CRSwNP has not responded to treatment (refractory disease)12.

Currently, after standard of care intranasal corticosteroids (INC), surgery and systemic corticosteroids are the main treatments for this disease all over the world. Many patients choose them; however, they are often not effective in controlling chronic symptoms over time, due to nasal polyp regrowth. After sinus surgery, nasal polyps recur in up to 80% of people, with approximately 40% requiring at least one additional surgery9. Approximately 80% of people remain uncontrolled 3-5 years after sinus surgery15.

Disclaimer This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'plan,' 'may,' 'could,' 'would,' 'expect,' 'anticipate,' 'seek,' 'look forward,' 'believe,' 'committed,' 'investigational,' 'pipeline,' 'launch,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Novartis Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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References 1. Xolair (omalizumab). SmPC 2. Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract 2016;4(4):565-572. 3. Newton JR and Ah-See KW. A review of nasal polyposis. Ther Clin Risk Manag 2008;4(2):507-512. 4. Bachert C. Evidence-based management of nasal polyposis by intranasal corticosteroids: from the cause to the clinic. Int Arch Allergy Immunol 2011;155(4):309-321. 5. Gevaert P, Omachi TA, Corren J, et al. Efficacy and safety of omalizumab in nasal polyposis: two randomized phase III trials. J Allergy and Clin Immunol 2020. doi.org/10.1016/j.jaci.2020.05.032 [online ahead of print]. 6. Patient. Nasal Polyps [online] February 24, 2017. Available from: https://patient.info/ears-nose-throat-mouth/nasal-polyps-leaflet [Last accessed: August 2020]. 7. Johns Hopkins Medicine. Could nasal polyps be the cause of your stuffy nose? Available from: https://www.hopkinsmedicine.org/health/articles-and-answers/ask-the-expert/stuffy-nose-nasal-polyps [Last accessed: August 2020]. 8. World Allergy Organization. Nasal Polyposis: A Multifactorial disease. Available from: https://www.worldallergy.org/educational_programs/world_allergy_forum/sydney/pawankar.php [Last accessed: August 2020]. 9. Bachert C, Zhang L, Gevaert P. Current and future treatment options for adult chronic rhinosinusitis: Focus on nasal polyposis. J Allergy Clin Immunol 2015;136(6):1431-1440. 10. Erskine S, Hopkins C, Kumar N, et al. A cross sectional analysis of a case-control study about quality of life in CRS in the UK; a comparison between CRS subtypes. Rhinology 2016;54(4):311-315. 11. Hoehle LP, Phillips KM, Bergmark RW, et al. Symptoms of chronic rhinosinusitis differentially impact general health-related quality of life. Rhinology 2016;54(4):316-322. 12. Khan A, Huynh TMT, Vandeplas G, et al. The GALEN rhinosinusitis cohort: chronic rhinosinusitis with nasal polyps affects health-related quality of life. Rhinology 2019;57(5):343-351. 13. Naclerio R, Baroody F, Bachert C, et al. Clinical research needs for the management of chronic rhinosinusitis with nasal polyps in the new era of biologics. A National Institute of Allergy and Infectious Diseases workshop. J Allergy Clin Immunol Pract 2020;8(5):1532-1549.e1. 14. Ye Z, Sun L, Wang Q. A head-to-head comparison of EQ-5D-5 L and SF-6D in Chinese patients with low back pain. Health Qual Life Outcomes 2019;17(1):57. 15. van der Veen J, Seys SF, Timmermans M, et al. Real-life study showing uncontrolled rhinosinusitis after sinus surgery in a tertiary referral centre. Allergy 2017;72(2):282-290.

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