FDA approves first drug for Eosinophilic Granulomatosis with ...
The U.S. Food and Drug Administration today expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune...
GSK says Nucala hits the target in new COPD trial
2 days ago · GSK's severe asthma therapy Nucala could find a new lease of life as a treatment for chronic obstructive pulmonary disease (COPD) after showing a clear benefit in a phase 3 trial.
GSK’s asthma blockbuster Nucala secures win in COPD Phase III trial
Sep 6, 2024 · GSK’s asthma drug Nucala (mepolizumab) has met the primary endpoint in a Phase III trial treating patients with chronic obstructive pulmonary disease (COPD). Data from the MATINEE study showed...
US FDA accepts GSK’s submission for the use of Nucala …
Dec 9, 2024 · GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for the use of Nucala (mepolizumab), as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with …
GSK’s twice-yearly asthma drug clears two phase 3 trials
6 days ago · GSK’s follow-up to severe asthma therapy Nucala, depemokimab, clears two phase 3 trials, reducing attacks compared to placebo with six-monthly dosing.
FDA to review GSK’s Nucala for COPD - Yahoo Finance
Dec 10, 2024 · The US Food and Drug Administration (FDA) has accepted a submission from GSK to review a new indication of Nucala (mepolizumab) as an add-on maintenance treatment for chronic obstructive...
GSK’s asthma blockbuster Nucala secures win in COPD Phase III trial
Sep 6, 2024 · GSK’s asthma drug Nucala (mepolizumab) has met the primary endpoint in a Phase III trial treating patients with chronic obstructive pulmonary disease (COPD). Data from the MATINEE study showed that when added to inhaled maintenance therapy, patients had a reduced annualised rate of moderate or severe exacerbations when compared to placebo.
GSK antibody drug reduces COPD attacks in trial | BioPharma Dive
Sep 6, 2024 · Nucala is a biologic therapy that targets a key messenger protein in the body called interleukin-5. It first won approval in 2015 for certain patients with severe asthma, and GSK believes it has the potential to treat a range of inflammatory conditions, including COPD.
GSK’s Nucala Gains Approval in China for CRSwNP - Yahoo Finance
Jan 4, 2025 · GSK announced that its monoclonal antibody, Nucala (mepolizumab), has been approved in China for treating adults with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition affecting 30...
GSK announces positive results for Nucala in COPD treatment
Sep 27, 2024 · A phase III clinical trial has found that Nucala (mepolizumab) has met the primary endpoint with a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations compared to a placebo in patients with COPD.