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 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).
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 posts COPD win for Nucala as Sanofi-Regeneron rival …
Sep 6, 2024 · GSK is heading into the weekend with a win for its respiratory blockbuster Nucala—but for now, the details are slim. On Friday, GSK said that its IL-5 antibody Nucala plus inhaled...
GSK announces U.S. FDA accepted its submission for use of Nucala …
Dec 9, 2024 · GSK (GSK) 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...
GSK antibody drug reduces COPD attacks in trial
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.
FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD
Dec 9, 2024 · GSK’s regulatory filing seeking the approval of Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype was supported by positive data from its phase III...
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...
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).
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.