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).
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 an ...
GSK says Nucala hits the target in new COPD trial
5 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 antibody drug reduces COPD attacks in trial
Sep 6, 2024 · GSK initiated the new study after failing to win approval for Nucala in COPD in 2018. At the time, the Food and Drug Administration asked for more clinical data to support the expanded indication. Nucala is a biologic therapy that targets a key messenger protein in the body called interleukin-5.
GSK: FDA Accepts For Review Submission For New Indication Of Nucala …
Dec 9, 2024 · (RTTNews) - British drug maker GSK plc (GSK, GSK.L) announced Monday that the U.S. Food and Drug Administration has accepted for review, data from the MATINEE study to support the regulatory...
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 - Pharmaceutical Technology
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 pulmonary disease (COPD) in individuals with an eosinophilic phenotype.
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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 Nucala and Blenrep receive regulatory boost in US and China
Dec 9, 2024 · (Alliance News) - GSK PLC on Monday received a double-dose of good news with its Nucala and Blenrep products receiving positive indications from industry regulators. GSK shares were up...