The first high-eosinophil syndrome (HES) targeted biologic drugs! FDA approves GlaxoSmithKline's third allergy!

!--, 2020 / --- GlaxoSmithKline (GSK) recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Nucala (mepolizumab, Mepolizumab) A new adaptive disorder for the treatment of patients with high eosinophil syndrome (HES), specifically: HES lasts for up to 6 months, unrecognized non-hematological secondary causes, adults and pediatric patients aged 12 years.
HES is a rare, life-threatening disease caused by eosinophilic inflammation, and treatment options are very limited.
it's worth noting that Nucala is the first and only targeted biological therapy approved for the treatment of this acidophil-driven disease, which will change the treatment landscape for HES patients.
HES is the third adaptive drug approved by Eucala, which has previously been approved as an additional maintenance therapy for severe acidophilic asthma (SEA), acidoblastoid granuloma (EGPA).
Nucala is the first treatment to be shown to reduce flares in HES disease (symptom deterioration or acidophil levels exceeding thresholds that require upgraded treatment).
the United States, the FDA has previously granted Nucala fast-track and orphan drug eligibility for treatment of HES, and in the European Union, the EMA has granted Nucala treatment of HES for orphan drug eligibility.
, GSK's chief scientific officer and president of research and development, said: "HES is a complex, life-threatening disease that affects nearly 5,000 patients in the United States.
today's approval gives these patients their first access to a biological therapy and reflects our commitment to maximizing the impact of Nucala on the treatment of acidophil-driven diseases.
"HES" (Photo: epainasist.com) this approval, based on positive results from critical Phase III clinical studies (NCT02836496).
a randomized, double-blind, placebo-controlled, 36-week study that assessed the efficacy and safety of Nucala's treatment of severe HES in adolescents and adults.
severe HES is defined as at least two HES flares in the last 12 months, with a blood-thymosphational granulocyte count of 1000 cells/microlith.
study, 108 patients were randomly assigned to receive a subsemptic injection of 300mg (3x100) or matching placebo every four weeks while continuing to receive their current HES therapy. The main endpoints of the
study were the proportion of patients who experienced a HES flare during 32 weeks of treatment, with secondary endpoints including: the time between the occurrence of the first HES flare (defined as the time between the start of randomization and the occurrence of the HES flare), the proportion of patients who experienced a HES flare during the 20-32 weeks of treatment, the annualization rate of HES flares, and the change in the fatigue severity relative to the baseline assessed according to the third assessment of the Simple Fatigue Scale (BFI).
results showed that the study reached its main endpoint: during the 32-week period of combined standard care treatment, the proportion of patients with a primary HES flare in the Nucala treatment group decreased significantly by 50 percent (56 percent vs. 28 percent, p-0.002) compared to the placebo group.
secondary endpoints of the study were also statistically significant and supported the main endpoint results, which showed that the risk of first HES flares in the Nucala treatment group was 66% lower over a 32-week period than in the placebo group (risk ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-0.67), heS flare annualization rate decreased by 66% (the occurrence ratio ratio was 0.34, 95% CI:0.19-0.63), and fatigue scores showed improvement (p=0.036).
results in this study are consistent with those known to Nucala.
Nucala is thought to work by lowering levels of acidophils in the blood, and there is evidence that the drug could be a targeted treatment option for a range of inflammatory diseases caused by an increase in eosinophils.
from these key Phase III studies is very encouraging and offers hope for HES patients.
HES is a rare disease that affects about 20,000 people worldwide and is characterized by the large number of acidic granulocytes found in blood and tissues that, over time, cause progressive damage to any organ of the body.
if left untreated, the disease can be fatal.
HES usually affects the skin, heart, lungs, gastrointestinal tract and central nervous system.
symptoms of HES may include cough, fever, fatigue, asthma, difficulty breathing, wheezing, recurrent upper respiratory tract infections, abdominal pain, vomiting, diarrhea, rash, arthritis, muscle pain, and joint pain.
Clinically, HES treatment aims to reduce eosinophils in the blood and tissues and prevent organ damage and slow progression of the disease, which typically includes glucoticoids, immunomodulation therapy and cytotoxic therapy.
Nucala's active pharmaceutical ingredient, mepolizumab, is a monoclonal antibody specific to target leucleocyte interleton 5 (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.
based on these mechanisms of action, Nucala is being developed for a variety of diseases caused by inflammation caused by eosinophils.
the drug has been evaluated in 21 clinical trials, more than 3,000 patients, and across multiple eosinophilopathy.
, GSK is also evaluating the potential of Nutala for the treatment of chronic nasal-sinusitis associated with nasal pneumosis (CRSwNP) and chronic obstructive pulmonary disease (COPD).
in late 2015, Nucala is the world's first biotherapy to target IL-5.
so far, Nucala has been approved by the United States, Europe and 20 other markets as an additional maintenance therapy for severe eosinophilic asthma (SEA) patients.
the United States and the European Union, Nucala has also been approved for the treatment of SEA pediatric patients aged 6-17 years.
addition, Nucala has been approved as an additional maintenance therapy for adult patients with acidoblastular granuloma (EGPA) in several markets, including the United States, Japan, and Canada.
() !--/ewebeditor:page--!--ewebeditor:page title"--the original source: FDA approves Nucala as first and only biologic for Hypereosinophilic Syndrome (HES) !--/ewebeditor:page--