CRSwNP competition intensifies GSK's IL-5 single anti-Nucala new adaptive application to be accepted by the FDA

CRSwNP is a chronic disease of the upper respiratory tract mainly caused by type 2 inflammation, characterized by polyps blocking the sinuses and nasal passages, the appearance of IL-4, IL-5, IL-13 and other type 2 inflammatory factors, as well as acidophils, alkaline granulocytes, fat cell tissue immersion.
current treatment options are endotental corticosteroids, systemic corticosteroids and surgery, but these treatments are not ideal and/or have a high recurrence rate.
patients may experience severe nasal obstruction, difficulty breathing, runny nose, loss or loss of sense of smell and taste, facial pain or compression.
continued symptoms of CRSwNP can have significant adverse effects on patients' health-related quality of life, including reduced productivity and daily activities, lack of access to food, lack of sleep and fatigue.
in recent years, the FDA has approved two new CRSwNP treatments, such as Sanofi/Regenerative's IL-4R alpha antibody Dupilumab and Roche's IgE antibody Xolair (omalizumab). ), dupixent was approved by the FDA in June 2019 as an additional maintenance therapy to treat under-controlled adult patients with severe chronic sinusitis with nasal diophritis (CRSwNP), becoming the world's first biological product to treat CRSwNP.
and Xolair was approved by the FDA earlier this month as an additional maintenance therapy for adult patients (≥18) who do not respond well to nasal corticosteroids.
addition, in September, AstraZeneone announced that its IL-5 monoantigen Fasenra phase 3 clinical trial OSTRO would significantly reduce the size of the nasal pneumoconia and the severity of nasal congestion in CRSwNP patients, and is expected to compete in the CRSwNP field in the future.
Nucala (Mepolizumab) is an all-human monoclonal antibody targeting leucin 5 (IL-5), which was approved by the FDA in 2015 to treat severe eosinophilic asthma (SEA), becoming the world's first approved IL-5 biological therapy.
the drug was subsequently approved by the FDA as an additional maintenance therapy for acidophilic granuloma combined with multiple inflammatory inflammation (EGPA) (2017/12) and eosinophil growth syndrome (HES) (2020/09).
the drug has been studied in more than 3,000 patients in 26 clinical trials of eosinophilosis and has been approved under the Nucala brand in the United States, Europe and more than 20 other markets for additional maintenance therapy for SEA and eosinophilic granuloma combined with multiple inflammation (EGPA).
this time, Nucala's application for treatment of CRSwNP's adaptation is based on the positive results of its key Phase III study SYNAPSE.
The study, designed in a randomized, double-blind, parallel group of more than 400 patients with severe double-sided nasal pyrethone, was designed to assess differences in efficacy and safety with the addition of mepolizumab (pre-charged syringe subsulte injections every 4 weeks for 52 weeks) and placebos based on standard therapies.
results showed significant improvements in nasal plyone size in the 52nd week and nasal obstruction scores in the 49-52 weeks in the imepolizumab treatment group compared to the placebo group.
the difference between the total score of the two groups of endoscopic nasal peeps was -0.73 (95% CI: -1.11, -0.34) and the difference between the baseline changes in the nasal obstruction VAS score was -3.14 (95% CI: -4.09, -2.18).
, there was also a significant difference in the time at which the mepolizumab treatment group and the placebo group performed their first pictomy surgery at 52 weeks, with a 57% reduction in the mepolizumab treatment group compared to the placebo group (HR 95% CI: 0.43 (0.25, 0.76).
Nucala will be the only treatment approved in the United States for four acid-thyrocyte-driven diseases and will be a new driver of sales growth if crSwNP is successfully approved in the future.
Nucala's global sales for 2018 and 2019 were $749 million and $952, respectively, according to GlaxoSmithKline, and sales in the first half of the year were 451 million pounds ($585 million) and are expected to exceed $1 billion this year.
in China, mepolizumab (Mepolizumab) is progressing slowly and is currently in the listing application stage (acceptance number JXSS2000021), but the declaration of what kind of adaptation is uncertain.
According to CDE's official website, the drug has submitted a number of clinical trial applications in China, including asthma, chronic obstructive pulmonary disease (COPD), acidophilic granuloma polyvascularitis (EGPA) and eosinophilic chronic sinusitis with nasal polyp, of which only phase III clinical trials for asthma are under way, while clinical trials for other adaptations have not yet been carried out.
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