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 asthma blockbuster Nucala secures win in COPD Phase III trial
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...
GSK’s twice-yearly asthma drug clears two phase 3 trials
4 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 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
3 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.
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 identifiable non-blood...
FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD
Dec 9, 2024 · GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment...
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...
USFDA accepts GSK submission for use of Nucala in COPD
Dec 11, 2024 · London: GSK plc has 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 an eosinophili...
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.