US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
3 days ago · 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: FDA Accepts For Review Submission For New Indication Of Nucala In COPD
3 days ago · GSK noted that recurrent exacerbations add to pressures on healthcare systems, and the COPD -related medical costs and others cost the US healthcare system around $7 billion a year.
GSK announces U.S. FDA accepted its submission for use of Nucala in COPD
3 days ago · 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 use ...
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 Accepts GSK’s Submission for Use of Mepolizumab in COPD
3 days ago · 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.. The Prescription Drug User Fee Act date is set for May 7, 2025, according to …
FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD
3 days ago · 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 ...
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 maintenance...
GSK antibody drug reduces COPD attacks in trial
Sep 6, 2024 · More than 300 million people around the world suffer from COPD, with about 40% exhibiting the type of inflammation affecting patients in GSK’s latest trial, according to the company. The disease can cause lung damage that leads to …
FDA to review GSK’s Nucala for COPD - Pharmaceutical Technology
2 days ago · 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.. GSK’s submission is supported by data from the MATINEE study, which assessed the therapy’s safety and efficacy.
GSK says US agrees to look at data for new use of COPD drug
3 days ago · “COPD affects more than 390 million people globally and over 14 million people in the US, exerting a significant burden on healthcare resources and the lives of patients,” GSK said on Monday.
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