Mepolizumab Under Review for Eosinophilic COPD
Dec 11, 2024 · The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for mepolizumab as an add-on maintenance treatment for chronic obstructive pulmonary disease with an eosinophilic phenotype.
Mepolizumab reduces exacerbations in COPD with type 2 …
Sep 16, 2024 · Adding GSK’s mepolizumab to standard inhaled treatment reduces the frequency of moderate to severe exacerbations in chronic obstructive pulmonary disease (COPD) patients with type 2 inflammation, which contributes to lung inflammation.
FDA Accepts GSK’s Submission for Use of Mepolizumab in COPD
Dec 9, 2024 · GSK announced today that the US FDA has accepted for review its submission to extend the use of mepolizumab (Nucala) as an add-on maintenance treatment for people with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.
Mepolizumab Significantly Reduces COPD Exacerbations
Sep 12, 2024 · Findings showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations with mepolizumab compared with placebo among patients treated for up to 104 weeks.
FDA to review mepolizumab for COPD with eosinophilic …
Dec 11, 2024 · The FDA has accepted to review a supplemental new drug application for mepolizumab, an anti-IL-5 biologic, for treating patients with COPD plus an eosinophilic phenotype, according to a GSK press...
FDA Accepts Nucala for COPD Review - Medthority
Dec 14, 2024 · The FDA has accepted GSK’s submission for Nucala (mepolizumab) as an add-on maintenance treatment for COPD with an eosinophilic phenotype. This decision is based on data from the MATINEE study, which showed significant reductions in moderate/severe exacerbations.
GSK’s Nucala Gains Approval in China for CRSwNP - Yahoo Finance
2 days ago · GlaxoSmithKline ( (GSK) ) has provided an update. GSK announced that its monoclonal antibody, Nucala (mepolizumab), has been approved in China for treating adults with chronic rhinosinusitis with ...
GSK announces positive results from phase III trial of Nucala ...
Sep 6, 2024 · GSK plc (LSE/NYSE: GSK) today announced positive headline results of MATINEE, the phase III clinical trial evaluating Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) in adults with chronic obstructive pulmonary disease (COPD).
MATINEE: Mepolizumab Significantly Reduces COPD …
Sep 9, 2024 · Mepolizumab was found to significantly reduce exacerbations in adults with chronic obstructive pulmonary disease (COPD), according to results from the MATINEE trial.
CHMP recommends Nucala for three new indications
Sep 22, 2021 · Nucala, a monoclonal antibody (mAb) that targets interleukin-5 (IL-5), has received positive opinions recommending approval in Europe for use in hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA) and chronic rhinosinusitis with nasal polyps (CRSwNP).