Key takeaways:
- The FDA primarily based mepolizumab’s approval on section 3 MATINEE and METREX trial outcomes.
- Mepolizumab has been assessed in sufferers with a blood eosinophil depend of at the very least 150 cells/μL.
The FDA granted approval to mepolizumab for treating adults with inadequately managed COPD and an eosinophilic phenotype, in response to a GSK press launch.
That is the second biologic authorised as an add-on upkeep remedy for COPD. As Healio beforehand reported, the FDA authorised dupilumab (Dupixent; Regeneron, Sanofi) as an add-on upkeep remedy in the identical affected person inhabitants in September 2024.
Nonetheless, the GSK launch highlighted that mepolizumab (Nucala, GSK) has been assessed in sufferers with a decrease blood eosinophil depend (BEC) threshold than dupilumab (≥ 150 cells/μL vs. ≥ 300 cells/μL).
“This choice is nice information for the way forward for COPD remedy in that there are actually extra choices exhibiting targets beforehand not recognized that may enhance affected person outcomes,” Gerard J. Criner, MD, FACP, FACCP, ATSF, creator on the MATINEE and METREX trials, chair and professor of thoracic drugs and surgical procedure at Lewis Katz College of Medication at Temple College and director of the Temple Lung Middle, informed Healio.
“Approving new therapies for COPD which might be chosen primarily based on biologic parameters can permit pulmonologists to be strategic within the therapies we provide for sufferers,” Criner, who can be a member of Healio’s Pulmonology Peer Perspective Board, mentioned.
As Healio beforehand reported, the FDA granted precedence assessment to mepolizumab in December 2024.
In accordance with the discharge, the choice was, partially, primarily based on findings from two randomized, double-blind, parallel-group, section 3 trials, each printed in The New England Journal of Medication: MATINEE in 2025 and METREX in 2017. Sufferers in each research have been on inhaled triple remedy.
Within the MATINEE examine, sufferers with reasonable to very extreme COPD and sort 2 irritation (BEC ≥ 300 cells/μL) receiving subcutaneous 100 mg mepolizumab vs. placebo each 4 weeks had a major lower within the annualized charge of reasonable or extreme exacerbations by 21% (charge ratio [RR] = 0.79; 95% CI, 0.66-0.94) at 52 weeks.
For exacerbations resulting in an ED go to and/or hospitalization, researchers additionally discovered that sufferers who obtained mepolizumab had a decrease annualized charge vs. placebo (RR = 0.65; 95% CI, 0.43-0.96). Nonetheless, this didn’t attain significance.
Notably, sufferers included on this trial had at the very least two reasonable or one extreme exacerbation prior to now 12 months and will have persistent bronchitis, emphysema or each, in response to the discharge.
A secondary evaluation of the MATINEE trial introduced on the 2025 American Thoracic Society Worldwide Convention additional confirmed that sufferers receiving mepolizumab vs. placebo had decreased reasonable and extreme exacerbation charges and fewer ED visits per exacerbation at 104 weeks.
Just like MATINEE, sufferers with COPD and an eosinophilic phenotype within the METREX trial receiving subcutaneous 100 mg mepolizumab vs. placebo each 4 weeks had an 18% vital lower within the annualized charge of reasonable or extreme exacerbations at 52 weeks (RR = 0.82; 95% CI, 0.68-0.98).
The discharge highlighted that sufferers with an eosinophilic phenotype on this trial had a BEC of at the very least 150 cells/µL at examine entry or at the very least 300 cells/µL inside the previous yr.
In each trials, researchers discovered that sufferers receiving mepolizumab and sufferers receiving placebo had comparable proportions of sufferers that skilled adversarial occasions.
“Right this moment there’s hope for improved look after COPD sufferers with an eosinophilic phenotype, together with these with a BEC threshold as little as [greater than or equal to] 150 cells/μL who want new choices like Nucala to assist their remedy journey,” Kaivan Khavandi, MBChB (MD), MRes, MRCP, PhD, MBA, senior vice chairman and international head of respiratory, immunology and irritation analysis and improvement at GSK, mentioned within the launch.
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Perspective
Mepolizumab’s approval firmly establishes that we’re within the period of biologics for COPD. It is usually a transparent indicator that pharma firms are investing a number of assets into enhancing COPD care. Lowering the danger for exacerbations is among the major remedy pathways in COPD, so any new addition to the medical armamentarium may be very welcome.
It is going to be attention-grabbing to see how the decrease blood eosinophil threshold impacts outcomes on the inhabitants degree. Whereas there’s ongoing debate about what the “proper” threshold must be, recommendation-setting our bodies like GOLD have held 300 cells/μL because the cutoff for eosinophilic COPD for some time now. Approval at 150 cells/μL may symbolize a significant step ahead. I haven’t had an opportunity to assessment the research at size simply but, however it should even be attention-grabbing to see if there are any subgroups that get pleasure from explicit profit (comparable to present people who smoke vs. former people who smoke), or if the enhancements in exacerbation threat run fairly evenly throughout the board.
I feel the largest challenges to its use in COPD will, as regular, be entry. Therapies don’t work in individuals who can’t acquire them, and we all know from the opposite remedy rollouts that individuals who may doubtlessly profit from mepolizumab will probably face a wide range of obstacles, from price to prescriber consciousness.
Hopefully, payers will swiftly acknowledge that decreasing exacerbations not solely improves high quality of life however reduces well being care prices as effectively. Advocacy teams such because the COPD Basis will, as all the time, be prepared to supply schooling and assist for prescribers, sufferers and caregivers who need to know extra about how biologics can enhance COPD administration.
It’s an thrilling and hopeful time for the COPD neighborhood!
Mike Hess, MPH, RRT, RPFT
Senior Director of Advocacy and Regulatory Affairs, COPD Basis
Member, Healio’s Pulmonology Peer Perspective Board
Disclosures: Hess experiences that the COPD Basis receives funding from numerous trade companions together with from the businesses with biologics authorised for COPD, Sanofi/Regeneron and GSK, however he doesn’t obtain any direct funds from both or anybody else in pharma.
