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 …
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 …
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 press...
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) …
US FDA accepts GSK’s submission for the use of Nucala (mepolizumab…
Dec 9, 2024 · The MATINEE study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.
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.
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 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 …
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.
FDA Approves First Drug to Treat Group of Rare Blood Disorders in ...
Sep 25, 2020 · Today FDA approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another …
- Some results have been removed