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European Commission Approves GSK's Nucala (Mepolizumab) for Three New Eosinophil-Driven Disease Indications

Nov 18, 2021 01:31 CST Updated 01:31
GSK

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European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.


Eosinophil-Driven Diseases (EDD, Image Source: astrazeneca.com)

November 17, 2021 /BioValleyBIOON/ --GlaxoSmithKline PLC.(GSK) recently announced that the European Commission (EC) has approved the anti-inflammatory drugNucala (mepolizumab), a monoclonal antibody that specifically targets and inhibits interleukin-5 (IL-5), is used to treat three eosinophil-driven diseases.: Hypereosinophilic Syndrome (HES), Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Eosinophilic Granulomatosis with Polyangiitis (EGPA).

In the EU, Nucala has previously been approved as an add-on therapy for the treatment of severe eosinophilic conditions in patients aged 6 years and above.Asthma(SEA) patients. Notably,Nucala is the only therapy approved in Europe for the treatment of four eosinophil-driven diseases, and also the first anti-IL-5 biologic therapy for the treatment of HES and CRSwNP, as well as the first targeted therapy for the treatment of EGPA.

In the United States, Nucala has been approved for the treatment of four indications: SEA, EPGA, HES, CRSwNP. Eosinophil-driven diseases, such as SEA, HES, CRSwNP, and EGPA, are inflammatory conditions characterized by elevated levels of eosinophils. Both HES and EGPA are rare diseases that can be life-threatening, and currently, patients have limited treatment options. CRSwNP can cause chronic symptoms such as nasal congestion and rhinorrhea. Patients with severe disease may require surgical treatment; however, polyps can recur, meaning patients may undergo repeated surgeries, with the efficacy of surgery gradually diminishing and risks increasing.

By reducing eosinophils in the blood to normal levels through targeted therapy, Nucala has demonstrated therapeutic benefits in a range of eosinophil-driven diseases.

This EU approval is based on data from a series of pivotal Phase 3 studies that investigated the role of Nucala in targeting IL-5 inhibition for the treatment of eosinophil-driven diseases. The study results showed: (1) In HES patients, during the 32-week study period, when combined with standard care, Nucala-treated patients experienced significantly fewer HES flares (symptom worsening or eosinophil levels exceeding thresholds requiring escalated treatment) compared to placebo. (2) In patients with CRSwNP who had undergone at least one surgery, when combined with standard care, Nucala demonstrated significant improvements in nasal polyp size at week 52 and in nasal congestion during weeks 49-52 compared to placebo, while also reducing the need for further surgery until week 52 of the study. (3) In EGPA patients, when combined with standard care, Nucala increased both the cumulative remission time and the proportion of patients achieving remission compared to placebo.

The active pharmaceutical ingredient in Nucala, mepolizumab, is a monoclonal antibody that specifically targets interleukin-5 (IL-5). IL-5 is a cytokine that regulates the growth, activation, and survival of eosinophils (a type of white blood cell) and provides critical signals for the migration of eosinophils from the bone marrow to the lungs and other organs. Nucala binds to human IL-5, blocking its interaction with the receptor on the surface of eosinophils. By inhibiting the binding of IL-5 to its receptor in this way, Nucala reduces eosinophil levels in the blood, tissues, and sputum, which in turn diminishes eosinophil-mediated inflammation.

Based on the aforementioned mechanism of action, Nucala is being developed for a variety of diseases caused by inflammation due to eosinophils. The drug has already been approved in 41Clinical Trial、More than 4,000 patients across various eosinophilic indications have been evaluated. GSK is also currently assessing the potential of Nucala in treating chronic obstructive pulmonary disease (COPD).

Nucala was approved at the end of 2015 and is the world's first biologic therapy targeting IL-5 to be marketed.As of now, Nucala has been approved in the United States, Europe, and more than 25 other markets as an add-on maintenance therapy for severe eosinophilic conditions.Asthma(SEA) patients. In the United States and the European Union, Nucala has also been approved for the treatment of pediatric SEA patients aged 6-17. Additionally, in multiple markets including the United States, Japan, and Canada, Nucala has been approved as an add-on maintenance therapy for adult patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA). In the United States, Nucala was also approved in September 2020 for the treatment of HES lasting ≥6 months, without an identifiable non-hematologic secondary cause, in adult and pediatric HES patients aged ≥12 years.

In July 2021, Nucala was approved in the United States as the first anti-IL-5 therapy for the treatment of CRSwNP. The specific indication is: add-on maintenance treatment for CRSwNP in adults aged 18 years and older with inadequate response to intranasal corticosteroids (INC). (Bioon.com)