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Sep 6, 2024 · Nucala is currently not indicated for COPD anywhere in the world About the mepolizumab development programme for COPD The mepolizumab program in COPD is comprised of three clinical trials The first two studies, METREX and METREO, completed in 2017 Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA Do not use to treat sudden breathing problems NUCALA can cause serious side effects, including: allergic (hypersensitivity) reactions, including anaphylaxis Serious allergic reactions can happen after you get your NUCALA injection --- gsk com european-commission-approves-nucala-mepolizumab-in-three-addi It has been studied in over 3,000 patients in 16 clinical trials across a number of eosinophilic indications and has been approved (under the brand name Nucala) in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with severe eosinophilic asthma and is the leading biologic in this indication Issued: 17 November 2021, London UK European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases · Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment for patients with hypereosinophilic syndrome or chronic rhinosinusitis with nasal polyps in Europepharmaphorum com eu-clears-gsks-asthma-drug-nucala-in-patient-friendly-fo finance yahoo com news fda-review-gsk-nucala-copd-093218027 htmlGSK says Nucala is the only drug in the new interleukin-5 inhibitor class to be approved in Europe in a once-monthly, self-administered format, adding that studies show 96% of patients prefer self --- nucala compatientworthy com 2021 12 nucala-approved-4-eosinophil-based-diseases-europeAs a result Nucala is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA) Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma Nov 17, 2021 · Issued: 17 November 2021, London UK European Commission approves Nucala (mepolizumab) in three additional eosinophil-driven diseases · Approval for the first targeted treatment for eosinophilic granulomatosis with polyangiitis and the first anti-IL-5 biologic treatment for patients with hypereosinophilic syndrome or chronic rhinosinusitis with nasal polyps in Europe Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA Do not use to treat sudden breathing problems NUCALA can cause serious side effects, including: allergic (hypersensitivity) reactions, including anaphylaxis Serious allergic reactions can happen after you get your NUCALA injection The Prescription Drug User Fee Act (PDUFA) date for the potential new indication is 7 May 2025 In November 2024, the European Commission approved a single-vial, fully liquid presentation of the Dec 2, 2015 · Nucala is currently approved for use in the 31 European countries covered by the European Medicines Agency (EMA) GSK Global Respiratory Franchise head and senior vice-president Eric Dube said: "The marketing authorisation of Nucala in the EU is a significant treatment advance for appropriate asthma patients and reinforces GSK’s leadership in Mepolizumab is now the only treatment approved in Europe for use in four eosinophil-driven diseases; GlaxoSmithKline (GSK) plc today announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), for use in three additional eosinophil-driven diseases pharmatimes com european_commission_approves_nucula_treatment_in_three_di Nucala is currently approved for use in the 31 European countries covered by the European Medicines Agency (EMA) GSK Global Respiratory Franchise head and senior vice-president Eric Dube said: "The marketing authorisation of Nucala in the EU is a significant treatment advance for appropriate asthma patients and reinforces GSK’s leadership in As a result Nucala is now approved for use in the 31 European countries covered by the European Medicines Agency (EMA) Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma --- gsk com european-commission-approves-nucala-mepolizumab-for-the-treat markets ft com data announce detail--- pharmaceutical-technology com newsgsks-nucala-gets-marketing-authoris GlaxoSmithKline (GSK) announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) for use in three additional eosinophil-driven diseases Nov 17, 2021 · GlaxoSmithKline (GSK) announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) for use in three additional eosinophil-driven diseases Nov 17, 2021 · Mepolizumab is now the only treatment approved in Europe for use in four eosinophil-driven diseases; 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