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On September 25, GSK announced that the U.S. FDA has approved Nucala (mepolizumab) for the treatment of adults and pediatric patients 12 years and older with unrecognized non-blood disorder secondary causes for up to 6 months.
this approval makes Nucala the first and only biological treatment approved in the United States for patients with acidophil-driven diseases.
FDA approval of Nutala is based on a priority review of data from a clinical development program that includes positive results from a key Phase 3 clinical study recently published in the Journal of Allergy and Clinical Immunology.
the 32-week randomized, double-blind, placebo-controlled critical study of 108 patients was designed to study the efficacy and safety of subsultural injections of mepolizumab 300 mg (3x100) every 4 weeks in uncontrolled HES patients 12 years and older compared to placebos.
In which uncontrolled HES is defined, at least two HES outbreaks (worsening symptoms or elevated thresholds for eosinophils requiring treatment) in the past 12 months and an increase in the count of haemophilic acidoblasts observed at screening are at 1000 cells/μL or higher. The main endpoints of the
study were the proportion of patients who experienced a HES outbreak during 32 weeks of treatment, with secondary endpoints including the time between the first HES outbreak (defined as the time between the start of randomization and the onion of heS outbreak), the proportion of patients experiencing an HES outbreak during the 20-32 weeks of treatment, the annualization rate of HES outbreaks, and changes in the relative baseline of fatigue severity assessed on the third assessment of the Simple Fatigue Scale (BFI).
study showed that during the 32-week study period, mepolizumab treatment reduced the number of patients with HES seizures (symptoms worsening or the threshold for eosinophils that needed to be treated) by 50 percent (28 percent to 56 percent ;p-0.002) to reach the main endpoint.
addition, the risk of the first HES outbreak in mepolizumab treatment was reduced by 66% compared to the placebo group (risk ratio of 0.34, 95% CI: 0.18-0.67), heS outbreak annualization The rate was reduced by 66% (the occurrence ratio ratio was 0.34, 95% CI: 0.19-0.63), the fatigue score showed improvement (p-0.036), and the secondary endpoint was also statistically significant.
results in this study are consistent with those known to Nucala.
first approved in 2015 for severe eosinophilic asthma (SEA) treatment, the first type of monoclonal antibody against IL-5.
the drug is believed to prevent IL-5 from binding to a subject on the surface of the eosinophils, reducing the blood acidophils to normal levels.
at normal levels, eosinophils may play a role in maintaining health.
Mepolizumab has been developed to treat diseases driven by inflammation caused by eosinophils.
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 acidophilic granuloma combined with multiple inflammatory inflammation (EGPA).
expected progress on regulatory applications for the drug to treat chronic sinusitis combined with nasal dupies (CRSwNP) by 2020.
, mepolizumab is currently being studied in COPD and has not been approved for use in relieving acute bronchial spasms or asthma.
source: 1.FDA approves Nucala as first and only biologic treatment for Hypereosinophilic Syndrome (HES) 2.Nucala (mepolizumab) is first treatment to show a large reduction in flares for patients with Hypereosinophilic Syndrome (HES)