Mepolizumab Under Review for Eosinophilic COPD
1 day ago · The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for mepolizumab as an add-on maintenance treatment for chronic obstructive pulmonary disease with an eosinophilic phenotype.The BLA is supported by data from the phase 3 MATINEE trial (ClinicalTrials.gov Identifier: NCT04133909), which evaluated mepolizumab, an interleukin-5 antagonist ...
GSK: FDA Accepts For Review Submission For New ... - Markets …
3 days ago · Mepolizumab is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), a key messenger protein (cytokine) in type 2 inflammation. ... For More Such Health News, visit rttnews.com ...
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 to review GSK’s Nucala for COPD - Yahoo Finance
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 ...
GSK: FDA Accepts For Review Submission For New Indication Of …
3 days ago · 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 review process to obtain a new indication for the use of Nucala (mepolizumab) in chronic obstructive pulmonary disease or COPD.The submission seeks an indication for the use of Nucala as an add-on maintenance treatment ...
FDA to review mepolizumab for COPD with eosinophilic …
1 day ago · The FDA has accepted to review a supplemental new drug application for mepolizumab, an anti-IL-5 biologic, for treating patients with COPD plus an eosinophilic phenotype, according to a GSK press ...
FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD
3 days ago · News & Insights. Smart Investing Markets Companies ... (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment for review. A decision from the regulatory body is expected on May 7 ...
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).
Mepolizumab Significantly Reduces COPD Exacerbations
Sep 12, 2024 · Findings showed a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations with mepolizumab compared with placebo among patients treated for up to 104 weeks.
Mepolizumab reduces exacerbations in COPD with type 2 …
Sep 16, 2024 · Adding GSK’s mepolizumab to standard inhaled treatment reduces the frequency of moderate to severe exacerbations in chronic obstructive pulmonary disease (COPD) patients with type 2 inflammation, which contributes to lung inflammation.
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