Targeted therapy for eosinophil disease! GlaxoSmithKline's Nucala enters EU review: Treating 3 new allergies!

October 30, 2020 // --- GlaxoSmithKline (GSK) recently announced that the European Medicines Agency (EMA) has accepted marketing of the anti-inflammatory drug Nucala (mepolizumab, Mepolizumab) Authorization Application (MAA) for the treatment of 3 new adaptations: high eosinophil syndrome (HES), chronic nasal-sinusitis with nasal polyps (CRSwNP), and acidoblastoid granulocytic multivascularitis (EGPA).
in the European Union, Nucala has previously been approved as an add-on therapy for the treatment of severe eosinophilic asthma (SEA) patients.
If approved, Nucala would be the only treatment in Europe for four acidophil-driven diseases, as well as the first biological treatment for HES and the first for EGPA.
the United States, Nucala has been approved to treat three adaptive disorders: SEA, EPGA, HES.
diseases driven by acidophils, such as SEA, HES, CRSwNP, and EGPA, are inflammatory diseases characterized by elevated levels of eosinophils.
HES and EGPA are rare diseases that can be life-threatening and currently have limited treatment options for patients.
CRSwNP can cause chronic symptoms such as nasal congestion and runny nose, and patients with serious illnesses may need surgery, but the pylodone may recur, meaning that patients undergo repeated operations that gradually become less effective and more risky.
the use of targeted therapy to reduce acidophils in the blood to normal levels, showing therapeutic benefits in a range of acidophil-driven diseases.
The three MAAs were based on the results of a series of key studies that showed that (1) in PATIENT patients, during the 32-week study period, when combined with standard care, there was a significant reduction in HES seizures in patients treated with Nucala (symptom deterioration or acidophil levels exceeding thresholds requiring upgraded treatment) compared to placebos.
(2) In patients with CRSwNP who underwent at least one operation, Nucala showed significant improvement in nasal pyveria size and nasal congestion at the end of the 52-week study compared to placebo, while reducing the need for further surgery until week 52 of the study.
(3) In EGPA patients, Nucala increased cumulative remission time and the proportion of patients who reached remission compared to placebos in combined standard care.
Nucala's active pharmaceutical ingredient, mepolizumab, is a monoclonal antibody specific to targeting 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.
these mechanisms, Nucala is being developed for a variety of diseases caused by inflammation caused by acidophils.
the drug has been evaluated in 26 clinical trials, more than 3,000 patients, and across multiple eosinophilopathy.
, GSK is also evaluating Nucala's potential for the treatment of chronic obstructive pulmonary disease (COPD).
, which was approved at the end of 2015, 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 is also 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.
U.S., Nucala was also approved in September to treat adults and pediatric patients with HES for ≥6 months, unrecognized non-hematological secondary causes, ages ≥12 years old.
() original source: GSK Nucala (mepolizumab) filings accepted by European Medicines Agency for three additional eosinophil-driven diseases