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GSK Receives CHMP Positive Opinion for Nucala (Mepolizumab) in Three Additional Eosinophil-Driven Diseases

Sep 19, 2021 10:20 CST Updated 10:20
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European Medicines Agency

The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.

Committee for Medicinal Products for Human Use

Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.


Eosinophil-driven diseases (EDD, Image source: astrazeneca.com)

September 19, 2021 /BioonBIOON/ --GlaxoSmithKline(GSK) recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval ofThe anti-inflammatory drug Nucala (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), and eosinophilic granulomatosis with polyangiitis (EGPA). The CHMP opinion will now be submitted to the European Commission (EC) for review, which typically makes a final decision within two months.

In the EU, Nucala was previously approved as an add-on therapy for the treatment of severe eosinophilicAsthma(SEA) patients. If the above three new indications are approved, Nucala will become the only therapy in Europe for the treatment of four eosinophil-driven diseases, as well as the first anti-IL-5 biologic therapy for HES and CRSwNP, and the first targeted therapy for EGPA.

In the United States, Nucala has been approved for four indications: SEA, EPGA, HES, and CRSwNP.Eosinophil-driven diseases, such as SEA, HES, CRSwNP, and EGPA, are inflammatory conditions characterized by elevated eosinophil levels. HES and EGPA are rare, potentially life-threatening diseases with currently limited treatment options. CRSwNP can cause chronic symptoms such as nasal congestion and rhinorrhea. Patients with severe disease may require surgical intervention; however, polyps may recur, necessitating repeated surgeries, which leads to progressively diminished surgical efficacy and increased procedural risks over time.

Reducing blood eosinophil levels to normal through targeted therapy has demonstrated therapeutic benefits in a range of eosinophil-driven diseases.The CHMP’s positive opinion is based on data from a series of pivotal Phase 3 studies investigating the role of targeted IL-5 inhibition by Nucala in the treatment of eosinophil-driven diseases. The results demonstrated: (1) In patients with HES, during the 32-week study period, when added to standard of care, Nucala significantly reduced HES exacerbations (worsening of symptoms or eosinophil levels exceeding a threshold requiring treatment escalation) compared to placebo. (2) In patients with CRSwNP who had undergone at least one surgery, when added to standard of care, Nucala demonstrated significant improvements in nasal polyp size at the end of the 52-week study and in nasal congestion during weeks 49–52 compared to placebo, while also reducing the need for further surgery through week 52 of the study. (3) In patients with EGPA, when added to standard of care, Nucala increased both the cumulative time in remission and the proportion of patients achieving remission compared to placebo.

The active pharmaceutical ingredient of 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 essential signaling for their migration from the bone marrow to the lungs and other organs. Nucala binds to human IL-5, blocking the binding of IL-5 to receptors on the surface of eosinophils. This inhibition of IL-5 receptor binding reduces eosinophil levels in the blood, tissues, and sputum, which in turn decreases eosinophil-mediated inflammation.

Based on the aforementioned mechanism of action, Nucala is being developed for various diseases driven by eosinophil-mediated inflammation. The drug has been in 41Clinical Trial、evaluated in over 4,000 patients across multiple eosinophilic indications. Currently, GSK is also evaluating the potential of Nucala for the treatment of chronic obstructive pulmonary disease (COPD).

Nucala was approved in late 2015 and is the first IL-5-targeting biologic therapy marketed globally.To date, Nucala has been approved in the United States, Europe, and more than 25 other markets as an add-on maintenance treatment for severe eosinophilic...Asthma(SEA) patients. In the United States and the European Union, Nucala is also approved for the treatment of pediatric patients aged 6 to 17 years with SEA. Additionally, in multiple markets including the United States, Japan, and Canada, Nucala has also 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 adult and pediatric patients aged ≥12 years with hypereosinophilic syndrome (HES) lasting ≥6 months and with no identifiable non-hematologic secondary cause.

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