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!--, 2020 // -- AstraZeneca recently announced that the new anti-inflammatory drug Fasenra (benralizumab, Benali pearl monoantigen) has reached the common end point of reducing nasal congestion and reducing nasal polyps (CRSwNP) in the treatment of chronic nasal sinusitis with nasal polyps (CRSwNP).
CRSwNP is a chronic disease that often occurs at the same time as other respiratory diseases and seriously impairs the quality of life of patients, including long-term nasal congestion, difficulty breathing and sleeping, and loss of sense of smell.
OSTRO is part of Fasenra's clinical trial project for the treatment of CRSwNP, which also includes ongoing Phase III ORCHID trials.
OSTRO is a randomized, double-blind, multi-center, parallel group, 56-week Phase III trial that is evaluating the efficacy and safety of Fasenra and placebo in patients with nasal polypic disease.
the study included 413 patients in Europe and North America, regardless of the count of hemophilic acidophils or whether they were associated with asthma.
these patients still have symptoms despite standard care (SoC) treatment.
SoC includes endotholsteroids (INCS), prior surgery, and/or the use of systemic corticosteroids.
study, patients were randomly grouped, with Fasenra injected 30 mg or placebo every 4 weeks for the first 3 doses and every 8 weeks thereafter.
The main outcome indicators were: (1) the effect of Fasenra on nasal pneo meat burden compared to placebo was assessed by changes in the total nasal pneo meat score (NPS) in endoscopy;
high-level results from the study from myhealthandwellnessinfo.com showed that Fasenra's treatment resulted in a statistically significant improvement in nasal psychic size and nasal obstruction in patients with chronic nasal-sinusitis with nasal dupy (CRSwNP) compared to placebo.
In patients with severe double-sided nasal pneosis who still had symptoms despite continued treatment with SoC, Fasenra resulted in statistically significant improvements in total nasal pneosis score (NPS) and nasal congestion score (NBS) compared to placebo.
the study, Fasenra's safety and tolerance were consistent with the drug's known drug characteristics.
Claus Bachert, lead researcher on the study, director of the otolaryngology department at the University Hospital of Dent, Belgium, and director of the Upper Alps Research Laboratory, said: "CRSwNP is difficult to treat and the underlying drivers of the disease and the history of natural diseases are not fully clear.
OSTRO study suggests that Fasenra's eosinophil depletion mechanism may benefit patients suffering from the disease.
, executive vice president of biopharmaceutical research and development at AstraZeneta, said: "CRSwNP patients have severe nasal congestion and a decline in quality of life.
current treatments, such as in-nose or oral corticosteroids and surgical excision of polyp, do not fully meet the patient's needs.
from the OSTRO study, Fasenra can benefit patients with nasal biopics.
look forward to completing the full analysis and sharing these results at an upcoming medical conference.
" chronic nasal-sinusitis with nasal diaphragm (CRSwNP) is characterized by persistent inflammation of the nasal cavity and sinus mucosa accompanied by benign growth, called nasal diaphragm.
can block the nasal passages, leading to breathing difficulties, loss of sense of smell, reduced nasal secretions, sleep disorders and other adverse effects on quality of life.
the disease is associated with elevated levels of eosinophils, a type of white blood cell that accumulates in the upper respiratory tract.
Currently, treatments for nasal polyps include in-nose or oral corticosteroids (OCS) and surgical removal of nasal polyps, but these methods often do not address the root cause of the disease and require repeated intervention.
since 2019, other biologic drugs have been approved or recommended for the treatment of nasal pyration.
June 2019, Sanofi and the regenerative anti-inflammatory drug Dupixent (Chinese: Dabito, generic name: Dupilumab) was approved for sale, becoming the first biotherapy to be approved for crSwNP treatment.
In August 2020, Novartis anti-inflammatory drug Xolair (Chinese brand name: Virki, generic name: omalizumab, omaju monoantigen) was approved, becoming the first treatment specifically targeting and blocking immunoglobulin E (IgE) for CRSwNP.
photo source: vasculitides.com Fasenra (benralizumab, benralizumab) The active pharmaceutical ingredient is benralizumab, a monoclonal antibody that binds directly to acidic granulocytes Alpha subi (IL-5R alpha) on the leukocyte mesokine 5 receptor, and uniquely attracts natural killing cells (NK cells), inducing rapid and almost complete depletion of eosinophils through apoptosis (procedural cell death).
Fasenra is AstraZenecom's first respiratory student preparation, approved by the United States, the European Union, Japan and a number of other countries as an additional (add-on) maintenance therapy for the treatment of severe acidophilic asthma patients.
currently, Fasenra is also being evaluated for the potential for the treatment of severe nasal polypulmonary disease, eosinophilic esophagealitis, acidophilic granuloma with polyvascularitis, eosinophil growth syndrome and chronic obstructive pulmonary disease.
it's worth noting that in April this year, GlaxoSmithKline's anti-inflammatory drug, Nucala (mepolizumab, Mepolizumab), tested positive in the critical Phase III SYNAPSE study, the first time an anti-IL-5 biologic agent has reported positive Phase III data in the treatment of CRSwNP.
is the world's first biotherapy to target IL-5.
IL-5 is a cytokine that regulates the growth, activity, and survival of eosinophils, a type of white blood cell, and provides important signals for the migration of eosinophils from bone marrow to the lungs and other organs.
Nucala binds to human IL-5, blocking the binding of IL-5 to the surface receptors of eosinophils.
inhibits the binding of IL-5 to receptors in this way, reducing levels of acidic granulocytes in blood, tissue, and sputum, which in turn reduces inflammation mediated by acidophils.
() !--/ewebeditor:page--!--ewebeditor:page title"--the original source: Fasenra met co--primary endpoints of the reduced nasal polyp and blockage in the OSTRO Phase III trial for patients with chronicsinusitis with nasalps !--/ewebitor