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HomeLatest Pharma-NewsEC approves new indication for Novartis Xolair® for rhinosinusitis

EC approves new indication for Novartis Xolair® for rhinosinusitis

Aug 06, 2020: “Novartis 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 control.

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 CRSwNP.

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Xolair is the first treatment for CRSwNP specifically targeting and blocking immunoglobulin E (IgE), a key driver in the inflammatory pathway of this disease.

Related News: lifepronow.com/2020/06/27/novartis-receives-positive-chmp-opinion-for-xolair-indication/

https://lifepronow.com/2020/01/13/novartis-ligelizumab-qge031-more-effective-than-xolairomalizumab-at-inhibiting-immunoglobulin-e-pathway-responsible-for-chronic-spontaneous-urticaria/

“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.”

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.

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 control.

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 airflow.

It is possible to have a single polyp or several, and the size of the polyps can vary from microscopic to several centimeters.”

https://www.novartis.com/news/media-releases/novartis-receives-ec-approval-new-xolair-indication-treat-severe-chronic-rhinosinusitis-nasal-polyps

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