Chronic sinusitis with nasal (CRSwNP) new drug! Novarro Xolair's new adaptations are approved by the European Union!

!--Webeditor:title"--August 07, 2020 // -- Novartis recently announced that the European Commission (EC) has approved the anti-inflammatory drug Xolair (Chinese brand name: Lying, generic name: omaliz omab, omajuma monotherapy) A new adaptive disorder, as an additional (add-on) therapy for endosinurtic steroids (INC), used to treat severe chronic nasal-sinusitis accompanied by nasal polyps (CRSwNP) adult patients with INC that do not adequately control the condition (AGE 18).
Phase III study showed that Xolair reduced the size of the nasal (defined by the nasal score (NPS) and improved symptoms and quality of life in patients with CRSwNP.
the approval builds on Xolair's efficacy and safety record, with more than 1.3 million patients with years of exposure and unparalleled real-world evidence of severe allergic asthma and chronic spontaneous urticaria.
CRSwNP is a chronic disease that often occurs in the same way as other respiratory diseases and seriously impairs the quality of life of patients, with symptoms such as long-term nasal congestion, difficulty breathing and sleep, and loss of sense of smell.
noteworthy, Xolair was the first treatment specifically to target and block immunoglobulin E (IgE), a key driver of the disease's inflammatory pathogenic path.
Xolair will provide a new treatment option for CRSwNP patients in Europe who are unable to adequately control their condition, significantly improving symptoms and quality of life.
2 POLYY Clinical Studies Data (click on the image for a 14th large picture) This new adaptation approval is based on the results of 2 Phase III Clinical Studies (POLYP 1, POLYP 2).
The two studies, randomized, multi-centered, double-blind, placebo-controlled, and repeating Phase III studies, assessed the efficacy and safety of Xolair in adult patients with CRSwNP who did not respond well to standard care therapy (endotolstrogen, INC).
138 patients in the POLYP 1 study and 127 patients in the POLYP 2 study, including those with or without a history of surgery. In the
study, these patients received Xolair or placebo injections every 2-4 weeks, as well as INC (Momisone Nasal Spray) as a background therapy, and the main endpoints of the two studies were changes in nasal pistometree score (NPS) relative to baseline and changes in average daily nasal congestion score (NCS) relative to baseline during 24 weeks of treatment.
the results of these two studies were published in the Journal of Perverted Responses and Clinical Immunology (JACI) in June 2020.
data showed that both studies reached common main endpoints: compared to the placebo group, patients in the Xolair treatment group averageDPS in the 24th week of treatment (POLYP 1:-1.08, p.lt;0.0001; POLYP 2:-0.9) Significant statistical improvements were achieved in 0, p,0.014) and daily NCS (POLYP 1:-0.89, p?0.0004; POLYP 2:-0.70, p?0.0017).
two studies, patients in the Xolair treatment group showed significant improvements in NPS and NCS as early as the first assessment (week 4) compared to patients in the placebo group.
in addition, two studies reached key secondary endpoints: improved health-related quality of life assessed by the Xolair treatment group in the nasal sinus outcome test-22 scale (SNOT-22), the University of Pennsylvania's Olfactory Identification Test (UPSIT), total nasal symptoms (TNSS), olfactory performance, and improvements in DDT (after nose leak) and runny nose (front nose).
two studies, Xolair was well tolerated and the safety was consistent with previous studies.
Nasal Polyp (Photo: myhealthandwellnessinfo.com) Nasal polyp is a common and potentially debilitating disease with limited treatment options available, and surgery and systemic steroids are the main treatments for the disease after standard care.
, however, these methods often fail to effectively control long-term chronic symptoms due to the regeneration of nasal.
nasal manifests itself as a non-cancerous lesion of the sinuses or inner wall of the nasal cavity, accompanied by irritation and inflammation, which can block normal airflow.
Nasal pups often occur in co-occurrence with other respiratory diseases, affecting about 45% of adults with severe asthma and about 30% of patients with chronic sinus-sinusitis, which can lead to chronic nasal-sinusitis associated with nasal (CRSwNP) if symptoms of nasal and sinusitis occur for 12 weeks or longer.
sinus surgery, the recurrence rate of nasal pouts is as high as 80%, and about 40% require at least one additional operation.
80% of patients remain out of control 3-5 years after sinus surgery.
noteworthy, in June and October 2019, Sanofi and Regenerative's anti-inflammatory drug Dupilumab was approved by the United States and the European Union to treat under-controlled CRSwNP adult patients.
the United States and the European Union, Dupixent was the first biotherapy to be approved for CRSwNP.
Xolair is the only approved anti-IgE antibody drug that specifically targets binding and blocks IgE.
by reducing free IgE, lowering high affinity IgE receptors, and limiting granulation cell granulation, Xolair minimizes media release during the perceptive inflammatory cascading process.
The drug is an injectable prescription drug that is prescribed by subderapor injection and has been approved for treatment in several countries around the world: moderate to severe persistent allergic asthma (SAA), chronic spontaneous urticaria (CSU) and chronic anaesthetic urticaria (CIU).
, Xolair pre-filled syringes have been approved for market in several countries around the world.
U.S. market, the drug was developed and marketed by Roche's Genenta in partnership with Novarro, while sales were recorded outside the U.S. market.
In China, Xolair (Chinese brand name: Cymdeitine, generic name: omajuma monotherapy) was approved in August 2017 for the treatment of patients over 12 years of age with moderate to severe allergic asthma who are poorly controlled by inhaled hormone-combined long-acting beta-2-epinephrine receptatrusants.
approval, making Xolair the first targeted drug approved in China to treat asthma.
() !--/ewebeditor:page-!--ewebeditor:page title"---Source: Novartis receives EC approval for new Xolair® indicate to treat chronic rhinosinusitis with nasal polyps !--/ewebeditor:page-.