Chronic nasal-sinusitis with new medicine for nasal polyps (CRSwNP) ! Novartis Xolair (Shwe, Omaju sema) New Indications is about to be approved in the European Union!

, June 28, 2020 //Bio valleyBIOON/Novartis
announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued a positive review recommending approval of the anti-inflammatory drug Xolair (Chinese brand name : Seomali, generic name: omalizumab, omazumab), as an additional (add-on) therapy for inthesic steroids (INC) in the nasal, used to treat adult patients with severe chronic sinary sinusitis associated with the condition that INC does not adequately control the condition (CRSwNP) (age 18)CRSwNP is a chronic disease that often occurs in parallel with other respiratory diseases and causes a range of symptoms that affect a patient's life, including loss of sense of smell and nasal congestionnow, CHMP's comments will now be referred to the European Commission, which is expected to make a final review decision within the next two monthsIf approved, Xolair will be the first treatment specifically designed to target and block immunoglobulin E (IgE) for nasal polyps, helping to reduce the size of nasal polyps (defined by nasal polyps) and improve disease symptomsCurrently, Xolair's new application for CRSwNP is also being reviewed in several countries, including the United States and Switzerland"CRSwNP patients continue to experience symptoms such as nasal congestion, facial pain, loss of smell and taste, breathing difficulties and sleep problems that can seriously damage their quality of life," said Professor Philippe Gevaert, of the Otolaryngology Research Laboratory at The University Hospital of Ghent in Belgium,Unfortunately, despite standard care and multiple sinus surgeries, many patients still develop symptomsXolair can target blockige, a key driver in the inflammatory pathway, and, if approved, the drug will provide patients with AN INC who are unable to adequately control the condition with a treatment option that has been shown to significantly improve symptoms and quality of life"
CHMP's positive review, based on the results of two Phase III clinical studies (POLYP 1, POLYP 2)The two studies, a randomized, multicenter, double-blind, placebo-controlled, repetitive Phase III study, assessed the efficacy and safety of Xolair in adult patients with CRSwNP who responded insufficiently to standard care therapy (nasal corticosteroids, INC)The POLYP 1 study enrolled 138 patients and polyP2 enrolled 127 patients, including those with or without a history of surgeryIn the study, these patients received an undercut injection of Xolair or a placebo every 2-4 weeks, along with INC (Momison nasal spray) as background therapy, and the common primary endpoint of both studies was changes in the nasal polyps score (NPS) relative to baseline scored within 24 weeks of treatment and changes in the relative baseline of the average daily nasal congestion score (NCS) the results of the two studies were published in the Journal of Allergy and Clinical immuno
logy (JACI) in June 2020 The data showed that both studies reached a common primary endpoint: patients in the Xolair treatment group had an average NPS (POLYP 1:1.08, p 0.0001; POLYP 2:-0.90) compared to the placebo group A statistically significant improvement was made in the daily NCS (POLYP 1:-0.89, p-0.0004; POLYP 2:-0.70, p-0.0017) In both studies, patients in the Xolair treatment group showed significant improvements in NPS and NCS as early as the first assessment (week 4) compared to those in the placebo group , two studies also reached a critical secondary endpoint: patients in the Xolair treatment group showed improvements in health-related quality of life in the nasal sinus outcome test -22 (SNOT-22), the University of Pennsylvania olfactory recognition test (UPSIT), total nasal symptoms (TNSS), olfactory, and improved post-nasal leakage (post-nasal leakage) and runny nose (front ale) compared to the placebo group In both studies, Xolair was well tolerated and its safety was consistent with previous studies "
Novartis is to reimagine and improve care for people with respiratory diseases, reduce symptoms and improve the quality of life of patients with respiratory diseases," said Dr Linda Armstrong, Head of Respiratory Development at Novartis Pharmaceuticals This positive advice from CHMP builds on The established efficacy and safety of Xolair, a drug that has been in contact with more than 1.3 million patients for more than 1.3 million years and has the potential to be an additional treatment option for crSwNP patients in the European Union "
nasal polyps (photo: myhealthandwellnessinfo.com) nasal polyps is a common and debilitating disease, with limited treatment options available, and surgery and systemic steroids are the main treatments for the disease after standard care However, due to the regeneration of nasal polyps, these methods are often not effective in controlling chronic long-term symptoms nasal polyps are characterized by non-cancerous lesions of the sinuses or the lining of the nasal cavity, accompanied by irritation and inflammation, which can block normal airflow Nasal polyps are often associated with other respiratory diseases, affecting about 45% of adults with asthma and about 30% of chronic sinusitis patients, which cause chronic nasal polyps and sinusitis for 12 weeks or more, leading to chronic nasal sinusitis associated with sinitus polyps (CRSwNP) After sinus surgery, the recurrence rate of nasal polyps is as high as 80%, and about 40% requires at least one additional operation About 80% of patients remain out of control 3-5 years after sinus surgery note, in June and October 2019, Sanofi and Regenerative Anti-inflammatory drug Dupixent (dupilumab) were approved by the United States and the European Union for the treatment of patients with poorly controlled CRSwNP patients Dupixent is the first biological therapy approved for CRSwNP in the United States and the European Union Xolair is the only approved anti-IgE antibody drug specifically targeted to bind and block IgE Xolair minimizes the release of media during the progenitor almange process by reducing free IgE, lowering the high affinity IgE receptor, and limiting the granulation of hypertrophic cells The drug is an injectable prescription drug that has been approved for treatment in several countries around the world: moderate to severe persistent allergic asthma (SAA), chronic spontaneous urticaria (CSU), and chronic irritated urticaria (CIU) In addition, Xolair pre-filled syringes have been approved for sale in several countries around the world In the U.S market, the drug was developed and promoted by Roche's Genentech in partnership with Novartis, while outside the U.S market was Novartis responsible for and recorded sales in China, Xolair (Chinese brand name: Stronger, generic name: Omazumab) was approved in August 2017 to treat patients over the age of 12 who are poorly controlled for moderate and severe allergic asthma treatment with inhaled hormone syllin combination with long-acting beta-2-epinephrine receptor agonis The approval makes Xolair the first targeted drug in China to approve asthma (BioValleyBioon.com) original source: Novart receivis positive CHMP opinion for new Xolair
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