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Nucala FDA Approval History

FDA Approved: Yes (First approved November 4, 2015)
Brand name: Nucala
Generic name: mepolizumab
Dosage form: Injection
Company: GlaxoSmithKline
Treatment for: Asthma, Eosinophilic Granulomatosis with Polyangiitis, Hypereosinophilic Syndrome

Nucala (mepolizumab) is an interleukin-5 antagonist monoclonal antibody (IgG1 kappa) indicated for the add-on maintenance treatment of patients ≥6 years with severe eosinophilic asthma, for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), and for the treatment of patients ≥12 years with hypereosinophilic syndrome (HES).

Development Timeline for Nucala

DateArticle
Sep 25, 2020Approval FDA Approves Nucala (mepolizumab) as the First and Only Biologic Treatment for Hypereosinophilic Syndrome (HES)
Sep 12, 2019Approval FDA Approves Nucala (mepolizumab) for Six to 11-Year-Old Children with Severe Eosinophilic Asthma
Jun  6, 2019Approval Nucala (mepolizumab) Gains FDA Approval for Two New Self-Administration Options
Dec 12, 2017Approval FDA Approves Nucala (mepolizumab) for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss Syndrome)
Nov  4, 2015Approval FDA Approves Nucala (mepolizumab) to Treat Severe Asthma
Jun 11, 2015GSK Announces Outcome of US FDA Advisory Committee Recommending Approval of Mepolizumab for Severe Asthma
Nov  5, 2014GSK Announces Regulatory Submissions for Mepolizumab in Severe Eosinophilic Asthma

Further information

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